FDA Adverse Event
Malfunction
Summary report: N
BENDING TEMPLATE RECONSTRUCTION PLATE 5 HOLES
MDR report key: 2724219
·
Received August 28, 2012
Report
- Report Number
- 8031020-2012-00197
- Event Type
- Malfunction
- Date Received
- August 28, 2012
- Date of Event
- August 8, 2012
- Report Date
- August 8, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
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
DURING SPS RECON PLATE SURGERY, THE SURGEON USED THE BENDING TEMPLATE THAT WAS NON-STERILE, W/O BEING STERILIZED. THE SURGEON HAD NOTICED THAT IT IS NON-STERILE WHILE USING THE BENDING TEMPLATE, HE WASHED THE WOUND OF PT AND SURGERY WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BENDING TEMPLATE RECONSTRUCTION PLATE 5 HOLES | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | X22510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |