FDA Adverse Event
Injury
Summary report: N
SCREW
MDR report key: 2822470
·
Received November 7, 2012
Report
- Report Number
- 2520274-2012-02970
- Event Type
- Injury
- Date Received
- November 7, 2012
- Report Date
- October 10, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
PATIENT IMPLANTED WITH NARROW LCP PLATE 7 HOLE AND SIX SCREWS ON (B)(6) 2012. PATIENT RETURNED FOR ROUTINE FOLLOW UP ON (B)(6) 2012 WITH AN X-RAY SHOWING TWO SCREW HEADS WERE BROKEN. PATIENT WAS RETURNED TO OR ON (B)(6) 2012, HARDWARE WAS REMOVED WITH THE EXCEPTION OF THE SHAFTS OF THE TWO BROKEN SCREWS REMAIN IN THE PATIENTS BONE. PATIENT WAS REVISED TO ANOTHER 7 HOLE PLATE AND SCREWS ON A DIFFERENT AREA OF THE BONE. IT IS REPORTED INFUSE BONE GRAFT WAS USED DURING REVISION TO NEW LCP LARGE FRAGMENT PLATE AND SCREWS. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention | PLATE, SCREWS| PLATE, SCREWS |