MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-07 for HALL SURGAIRTOME 5058-01 manufactured by Linvatec Corporation D/b/a Conmed Linvatec.
[119497105]
Surgitome required for right first metacarpophalangeal joint (mpj) fusion did not function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7854712 |
| MDR Report Key | 7854712 |
| Date Received | 2018-09-07 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-08-29 |
| Report Date | 2018-08-30 |
| Date Reported to FDA | 2018-08-30 |
| Date Reported to Mfgr | 2018-09-07 |
| Date Added to Maude | 2018-09-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL SURGAIRTOME |
| Generic Name | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED |
| Product Code | GET |
| Date Received | 2018-09-07 |
| Model Number | 5058-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINVATEC CORPORATION D/B/A CONMED LINVATEC |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-07 |