FDA Adverse Event
Injury
Summary report: N
TARGET DEVICE 300X160MM
MDR report key: 2032692
·
Received March 17, 2011
Report
- Report Number
- 9610622-2011-00118
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 3, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
HEAD OF THE THEATRE, REPORTED VIA OUR SALES REP, THAT DURING A SURGERY, HE TRIED TO IMPLANT THE NAIL WITH THE TARGET DEVICE. FURTHER HE REPORTED, THAT IT WAS NOT POSSIBLE TO LOCK THE NAIL WITH THE LAG SCREW. HE REPORTED THAT A SECOND TRY FAILED. THE SURGERY WAS DELAYED BY TWO HOURS AND A REVISION SURGERY FOLLOWED. DR. REPORTED THAT HE USED A SUBSTITUTE INSTRUMENT (T2 FEMUR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE 300X160MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KME901663 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |