FDA Adverse Event
Malfunction
Summary report: N
BENDING TEMPLATE CALCANEAL PLATE 50MM
MDR report key: 2945741
·
Received January 4, 2013
Report
- Report Number
- 8031020-2013-90003
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 14, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING SPS CALCANEAL PLATE SURGERY, THE SURGEON USED THE BENDING TEMPLATE OF NON-STERILIZATION, WITHOUT STERILIZATION PROCESSING IN THE HOSPITAL. BECAUSE THE SURGEON HAD NOTICED THAT IT IS NON-STERILIZATION WHILE USING THE BENDING TEMPLATE, HE WASHED A WOUND OF PATIENT. AND THE OPERATION USED ONLY HYDROXYAPATITE AND COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5773 | BENDING TEMPLATE CALCANEAL PLATE 50MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | X14127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |