FDA Adverse Event
Injury
Summary report: N
LAG SCREW, TI GAMMA3® Ø10.5X95MM
MDR report key: 4100413
·
Received September 19, 2014
Report
- Report Number
- 0009610622-2014-00477
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- August 29, 2014
- Report Date
- August 29, 2014
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A REVISION DUE TO A BONE FRACTURED. THE LAG SCREW IN GAMMA NAIL HAD PROTRUDED. DOCTOR THEN REVISED THE LAG SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583972 | LAG SCREW, TI GAMMA3® Ø10.5X95MM | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER TRAUMA KIEL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |