FDA Adverse Event
Injury
Summary report: N
1.3MM TI Y-PLATE/3 HOLES HEAD 8 HOLES SHAFT/32MM
MDR report key: 1882499
·
Received October 21, 2010
Report
- Report Number
- 3003506883-2010-00055
- Event Type
- Injury
- Date Received
- October 21, 2010
- Report Date
- September 28, 2010
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- HRS
- PMA / PMN Number
- K912932
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
STATUS POST PLATE AND SCREW IMPLANTATION PATIENT RETURNED TO SURGEON'S OFFICE FOR POST OP VISIT. AN X-RAY SHOWED THE PLATE WAS BROKEN WITH THE SCREWS INTACT. SURGEON REMOVED THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.3MM TI Y-PLATE/3 HOLES HEAD 8 HOLES SHAFT/32MM | TI Y-PLATE | HRS | SYNTHES ELMIRA | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | SCREW |