FDA Adverse Event
Injury
Summary report: N
2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
MDR report key: 3121536
·
Received May 21, 2013
Report
- Report Number
- 1719045-2013-01452
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- April 23, 2013
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HRS
- PMA / PMN Number
- K063049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH HARDWARE IN THE LEFT FOOT. THE PATIENT DEVELOPED PAIN ON AN UNKNOWN DATE. REVISION SURGERY TOOK PLACE ON (B)(6) 2013 TO REMOVE THE PAINFUL HARDWARE. A BROKEN PLATE, SCREWS, AND "PENTACAL" SCREWS WERE REMOVED. THE FRACTURE HAD HEALED. A 2.7MM LOCKING SCREW AND A 2.7MM CORTEX SCREW WERE FOUND TO BOTH HAVE THE HEAD REMOVED. THE SHAFTS OF BOTH SCREWS REMAIN IMPLANTED. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224751 | 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM | HRS | SYNTHES MONUMENT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |