FDA Adverse Event
Malfunction
Summary report: N
ROD TO ROD COUPLING HOFFMANN II MICRO 3/3MM
MDR report key: 2112204
·
Received April 29, 2011
Report
- Report Number
- 8031020-2011-00090
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 12, 2011
- Report Date
- April 12, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- KTT
- PMA / PMN Number
- K042019
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, PREPARING TO APPLY EXTERNAL FIXATION WHEN THE DOCTOR CAME OVER TO THE TABLE TO EXAMINE THE SET. WE FOUND UPON EXAMINATION THAT EVERY ITEM WAS RUSTED. THE RUST ON THE ITEM WAS INSIDE ON THE SPRING ONLY NOTICED UNDER CLOSE INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROD TO ROD COUPLING HOFFMANN II MICRO 3/3MM | IMPLANT | KTT | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |