FDA Adverse Event
Injury
Summary report: N
HUNTER TENDON ROD
MDR report key: 2671400
·
Received July 26, 2012
Report
- Report Number
- 1043534-2012-00891
- Event Type
- Injury
- Date Received
- July 26, 2012
- Date of Event
- April 10, 2012
- Report Date
- July 3, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HXA
- PMA / PMN Number
- K853438
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.
Description of Event or Problem · 1
ALLEGEDLY BROKEN TENDON ROD NOTICED ON X-RAY IMMEDIATELY AFTER IMPLANTATION. PRODUCT REMOVED SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUNTER TENDON ROD | SMALL JOINT COMPONENT, CODE:HXA | HXA | WRIGHT MEDICAL TECHNOLOGY, INC. | 0211312810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |