FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE 300X160MM
MDR report key: 1190576
·
Received October 2, 2008
Report
- Report Number
- 9610622-2008-00180
- Event Type
- Malfunction
- Date Received
- October 2, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 5, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "GAMMA3 NAIL FUSED TO THE TARGETING ARM. SURGEON HAD TO REMOVE LAG SCREW, DISTAL LOCKING SCREW, NAIL, AND TARGETER. SURGEON USED A DIFFERENT GAMMA SYSTEM AND INSERTED INTO PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE 300X160MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KME90124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Other |