FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT - TARGET DEVICE
MDR report key: 1203013
·
Received October 17, 2008
Report
- Report Number
- 9610622-2008-00198
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 25, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "ON INITIAL SURGERY, DISTAL LOCKING SCREW MISSED THE LOCKING HOLE, SKIRTED AROUND THE NAIL CAUSING STRESS RISER IN FEMORAL CORTEX. SCREW WAS THEN PLACED CORRECTLY. PERI-PROSTHETIC FRACTURE HAPPENED. ALL THREE COMPONENTS WERE REMOVED AND REPLACED WITH A LONG NAIL. THE SHORT NAIL SHOWS SIGNS OF SCALPING AROUND THE HOLE CAUSED BY THE SCREW. PATIENT KEPT ALL IMPLANTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - TARGET DEVICE | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |