FDA Adverse Event
Injury
Summary report: N
LAG SCREW, TI 10.5X75MM
MDR report key: 2132593
·
Received June 10, 2011
Report
- Report Number
- 9610622-2011-00245
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- May 24, 2011
- Report Date
- May 24, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 NAIL. AFTERWARDS, THE SURGEON FOUND THROUGH THE X-RAY THAT THE LAG SCREW HAD BEEN CUT OUT FROM THE FEMORAL HEAD. THEREFORE THE SURGEON IS SCHEDULING THE EXTRACTION OPERATION OF THE IMPLANTS ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAG SCREW, TI 10.5X75MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K831568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |