FDA Adverse Event
Injury
Summary report: N
7.3MM CANNULATED SCREW 32MM THREAD/100MM
MDR report key: 2895868
·
Received January 3, 2013
Report
- Report Number
- 1719045-2013-00007
- Event Type
- Injury
- Date Received
- January 3, 2013
- Report Date
- December 5, 2012
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWC
- PMA / PMN Number
- K962011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- HEALTH 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 CANNULATED SCREWS ON (B)(6) 2011. ON AN UNKNOWN DATE, PATIENT COMPLAINED OF PAINFUL HARDWARE FROM AVASCULAR NECROSIS (AVN) OF THE LEFT FEMUR. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 AND THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3641 | 7.3MM CANNULATED SCREW 32MM THREAD/100MM | SCREW | HWC | SYNTHES MONUMENT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention | SCREWS |