FDA Adverse Event
Injury
Summary report: N
2520274-2013-01470
MDR report key: 3003783
·
Received March 14, 2013
Report
- Report Number
- 2520274-2013-01470
- Event Type
- Injury
- Date Received
- March 14, 2013
- Report Date
- February 20, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH HARDWARE ON AN UNKNOWN DATE FOR A HIP PINNING. PATIENT FELL ON AN UNKNOWN DATE AND HEARD A POP. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED THREE 7.3MM CANNULATED SCREWS BROKE POST-OPERATIVELY. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE AND PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THIS REPORT IS FOR AN UNKNOWN 7.3MM CANNULATED SCREW. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107341 | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |