FDA Adverse Event
Injury
Summary report: N
TI ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/97MM
MDR report key: 2011670
·
Received March 3, 2011
Report
- Report Number
- 8030965-2011-00033
- Event Type
- Injury
- Date Received
- March 3, 2011
- Report Date
- February 1, 2011
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- HRS
- PMA / PMN Number
- PREAMEND
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Description of Event or Problem · 1
DEVICE REPORT RECEIVED FROM SYNTHES (B)(6). CUSTOMER NOTIFIED THE (B)(6) THAT TWO OF THE SCREWS IMPLANTED (B)(6), 2010 FOR A FIBULA FRACTURE, BROKE POSTOPERATIVELY. HARDWARE WAS REMOVED (B)(6), 2011. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/97MM | TUBULAR PLATES | HRS | SYNTHES ELMIRA | NA | 2498826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREWS| PLATE |