Patient-Specific Implant Case File Verification demo
Custom implants held when an as-built hole or bend differs from the revision the surgeon approved, even after passing every inspection. 1:26
What the demo shows
A case file check for patient-specific implants: parts and records match the signed design.
Seven agents read every record in a case file, lock the revision the surgeon signed, compare every as-built screw hole and bend from the inspection report with that revision's plan, check side, the design envelope and every label item, and hold the case when anything differs, opening a nonconformance record. The design engineer reviews and proposes a disposition and QA release agrees; only the surgeon approves a design for her patient; QA release releases each case alone. The agents never change, approve or release a design.
Transcript
- Patient-Specific Implant Case File Verification checks custom implants against the surgeon's signed design.
- For implant teams: FDA asks patient-matched devices to carry their design version.
- Seven agents lock the signed revision two: bend two is six degrees off.
- The plate follows revision three and passed inspection against it; the case is held.
- Linnea, the design engineer, opens revision three and the design envelope and reads both.
- She signs with her own reason: use it only if the surgeon agrees.
- Perrine in QA release opens the inspection report and the nonconformance record and reads each one herself.
- She agrees in her own words, so revision three goes to the surgeon.
- Agents and people sign as themselves, on one audit trail.
- One wrong bend held before shipping; release waits for the surgeon's signature.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.