FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE, G3 PLUS
MDR report key: 2942312
·
Received January 8, 2013
Report
- Report Number
- 9610622-2013-90013
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 28, 2012
- Report Date
- December 18, 2012
- Manufacturer
- STRYKER TRAUMA GMBH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE NURSE REPORTED TO OUR SALES REP THAT IT WAS OBSERVED DURING A SURGERY THAT THE CARBON AREA OF THE TARGET DEVICE WAS CRACKED. THE SURGEON COULD COMPLETE THE SURGERY WITHOUT ANY DELAY OR CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10364 | TARGET DEVICE, G3 PLUS | INSTRUMENT | LXH | STRYKER TRAUMA GMBH | NA | KP26453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |