FDA Adverse Event
Injury
Summary report: N
3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM
MDR report key: 3944460
·
Received July 18, 2014
Report
- Report Number
- 3009450871-2014-10252
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- June 20, 2014
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HWC
- PMA / PMN Number
- PK121601
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO A FRACTURE COLLAPSE. THE PATIENT PREVIOUSLY UNDERWENT A 3.5 MM PROXIMAL TIBIAL PLATE SURGERY THREE MONTHS AGO. THE FRACTURE COLLAPSED BECAUSE PATIENT DIDN'T FOLLOW DIRECTIONS AND WALKED ON IT TOO SOON. NO PRODUCT PROBLEM NOTED AND NOTHING WRONG WITH HARDWARE. THIS REPORT IS FOR 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421497 | 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM | PLATE,FIXATION,BONE | HWC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |