FDA Adverse Event
Injury
Summary report: N
ORTHOLOC(TM) 3DSI CLAW(R) II PLATE
MDR report key: 3070509
·
Received April 22, 2013
Report
- Report Number
- 1043534-2013-00658
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- February 14, 2013
- Report Date
- March 6, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HRS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. X-RAYS WERE PROVIDED AND REVIEWED. PHOTOGRAPHIC IMAGES WERE MADE OF THE RETURNED PRODUCT.(B)(4).
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY BROKEN PLATE DUE TO NON-UNION. POSSIBLE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171713 | ORTHOLOC(TM) 3DSI CLAW(R) II PLATE | SMALL JOINT COMPONENT, CODE:HRS | HRS | WRIGHT MEDICAL TECHNOLOGY, INC. | 1420432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |