Which device, which lot
The implant sticker, the device identifier and the lot, pulled from the operative report so product identification rests on a page.
UDINewMissing Records Detection: flags every visit, provider, and date missing from the file. See how →
- Solutions
- Case types
- Product liability
Specific causation is decided on the alternatives nobody ruled out. Find them first.
Medrecords AI lines up the device history with the clinical course: the implant and its lot, the labeling in force at the time, the symptoms, the workup and every other cause the chart records. Every entry links to its page. The causation opinion stays with your expert.
- HIPAA, under a BAA
- SOC 2
- 100 pages a minute
- First case is free on us
1 implant, 2 historiestap a point
Device history
Clinical course
11 Nov 2022OrthopedicsClinical course
Fall at home 3 weeks earlier noted in history.
Illustrative case. The patient, device, dates and pages are fictional.
30days
The deadline for a device maker to report a death or serious injury to FDA after it learns of it.
21 CFR §803.502parts
A unique device identifier: a device identifier for the model and a production identifier for the lot or serial.
21 CFR §801.32023amendment
Rule 702 now asks the court to find an expert opinion more likely than not reliable before a jury hears it.
Fed. R. Evid. 702100pages a minute
How fast Medrecords AI reads the file.
Medrecords AI
Where product cases turn
Device history Device history Device history Clinical course Clinical course Both
6 places the manufacturer looks first. The chronology gets you there before they do.
A product case is fought on specific causation, and the defense wins it by pointing at a cause nobody ruled out. These are the pages it reaches for, flagged before it gets there.
The label at the time
The instructions and warnings in force on the date of use, set beside what the treating physician wrote.
label at implantThe explant
What happened to the removed device: pathology, retention, chain of custody. A missing step is flagged with the page that should have it.
flaggedSymptom onset
The first note of each symptom, dated and quoted, so the exposure window and the injury window can be compared.
citedEvery other cause
Prior conditions, other injuries, other drugs and devices the chart records, each with its page. The alternatives your expert has to address.
other cause notedThe records that never arrived
The pathology slides, the device return form, the imaging a referral ordered. Listed with the page that points to each one.
missing-records list
Sample output
What comes back: the device and the patient on 1 timeline, every line cited.
| Date | Source | Finding | Page | Flag |
|---|---|---|---|---|
| 1 Jan 2021 | Instructions for use | Labeling in force at implant: revision 4, no warning on metal ion testing. | p. 5 | label at implant |
| 3 Mar 2021 | Operative report | Left total hip arthroplasty. Implant sticker lists the device identifier and lot. | p. 22 | UDI on file |
| 15 Aug 2022 | Manufacturer letter | Field safety notice for the lot. Copy in the patient file. | p. 190 | cited |
| 9 Jan 2023 | Revision surgery | Components explanted and sent to pathology. No chain of custody form. | p. 240 | missing custody record |
| Date | Source | Finding | Page | Flag |
|---|---|---|---|---|
| 14 Nov 2019 | Orthopedics | Left hip osteoarthritis. Body mass index 34. | p. 12 | other cause noted |
| 20 Jun 2022 | Primary care | Groin pain 6/10. X-ray ordered. | p. 150 | symptom onset |
| 5 Oct 2022 | Lab | Serum cobalt and chromium elevated. | p. 171 | cited |
| 11 Nov 2022 | Orthopedics | Fall at home 3 weeks earlier noted in history. | p. 182 | other cause noted |
| 2 Feb 2023 | Pathology | Metallosis with pseudotumor tissue. | p. 251 | cited |
| 1 Jun 2023 | Physical therapy | Discharge. Walks with a cane. | p. 298 | cited |
Fictional case built for this page. Real output carries the same columns, with every page linked to the source PDF.
How it works
Send the medical file. Get the causation record back.
What you send
- Operative reports, implant logs and device stickers
- Treating, imaging, lab and pathology records
- Labeling, recall and safety notices you have
- Pharmacy records for drug cases
- Any format: PDFs, scans, faxes, phone photos
What you get
- A page-cited chronology of exposure, symptoms and workup
- Device identification pulled from the operative record
- Every alternative cause the chart records, with pages
- Labeling in force on the date of use, beside the clinical course
- A list of records the file refers to but does not contain
We lay out the record. Your expert gives the causation opinion.
We assemble and cite the device history, the clinical course and the alternatives the chart records. We do not say the product was defective, that it caused the injury, or that another cause is ruled out. Those opinions belong to your retained experts.
HIPAA, under a signed BAAEvery file is handled under our Business Associate Agreement.
SOC 2Encryption in transit and at rest, and PHI access logging on every event.
Never trains a modelYour records never train any AI model, ours or anyone else’s.
Deleted on requestRetention is configurable and deletion is on request, with an audit log of every access.
Questions
Product liability record review, answered.
Do you offer a causation opinion?
No. General and specific causation are expert opinions offered under Rule 702. We assemble the cited record they are formed on: the exposure window, the workup, the alternative causes documented in the chart, and the labeling in force at the time.
Why surface alternative causes for the plaintiff side?
Because the defense expert will find them, and an opinion that never addressed a documented comorbidity is the one that gets excluded. Surfacing them early, with pages, is what lets your expert address them in the report rather than at the hearing.
Do you research the scientific literature?
No. Literature selection and interpretation are the expert’s methodology. We work the case file and the labeling and adverse event record you supply, and cite every extraction to its page.
Do you retrieve records from providers?
No. Medrecords AI does not retrieve records from providers or facilities. You bring the records you already have, and review starts in minutes from upload. Retrieval vendors take days. You can keep yours and still cut the review to minutes.
Related case types
Send us 1 product file. The first case is free on us.
Book a short demo. After it we open trial access on one of your own cases, the first one free on us, with the causation record back page-cited.
Sources
Every rule, regulation, statute and published standard named on this page is linked below to the text the body that issues it puts out, read on the date shown. Where a standard is sold rather than published, the link goes to its publisher's page for it. A few rules are named without a link, because no source we could read and confirm publishes them.
- 21 CFR 801.3 — eCFR, read 25 Sep 2026
- 21 CFR 803.50 — eCFR, read 25 Sep 2026
- Fed. R. Evid. 702 — Cornell LII, read 25 Sep 2026