FDA Adverse Event
Injury
Summary report: N
2520274-2013-05891
MDR report key: 3320678
·
Received August 31, 2013
Report
- Report Number
- 2520274-2013-05891
- Event Type
- Injury
- Date Received
- August 31, 2013
- Report Date
- August 8, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 10 UNKNOWN LOCKING SCREWS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: HTY, JDW, HRS. THE FILE WAS REVIEWED ON THIS DATE AND IT WAS NOTICED THAT THE INCORRECT PATIENT AGE WAS PROVIDED ON THE INITIAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT SUSTAINED A DISTAL FEMUR NON-UNION WHICH RESULTED IN A BROKEN 4.5MM CONDYLAR LOCKING COMPRESSION PLATE. THE PATIENT UNDERWENT A SECOND SURGERY TO DEBRIDE THE NON-UNION AND RE-PLATE. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433474 | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |