FDA Adverse Event
Injury
Summary report: N
2.7MM CORTICAL SCREW 12MM LONG
MDR report key: 3254050
·
Received July 26, 2013
Report
- Report Number
- 3004608878-2013-00143
- Event Type
- Injury
- Date Received
- July 26, 2013
- Report Date
- July 26, 2013
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HRS
- PMA / PMN Number
- K093163
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
"BROKEN SCREW IN WRIST FUSION PLATE". IT WAS REPORTED FOLLOWING SURGERY, THE PATIENT EXPERIENCED DISCOMFORT. AN X-RAY RECEIVED A FRACTURED SCREW AND THE PATIENT'S WRIST DID NOT FUSE. THE SCREW WAS REMOVED ON (B)(6) 2013. ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349547 | 2.7MM CORTICAL SCREW 12MM LONG | WRIST FUSION NON STERILE IMPLANTS | HRS | INTEGRA LIFESCIENCES CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |