FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE 300X160MM
MDR report key: 1053477
·
Received May 28, 2008
Report
- Report Number
- 9610622-2008-00067
- Event Type
- Malfunction
- Date Received
- May 28, 2008
- Date of Event
- May 2, 2008
- Report Date
- May 5, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ADD'L LOT NUMBER: KP214193.
Description of Event or Problem · 1
REFERRING TO PREVIOUS REPORTED COMPLAINTS IN WHICH A REVISION SURGERY BECAME NECESSARY DUE TO THE NAIL FRACTURING. THE CUSTOMER ASSUMES A MALFUNCTION WITH THE TARGET DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE 300X160MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KP230904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |