FDA Adverse Event
Malfunction
Summary report: N
ADAPTER NUT
MDR report key: 2050579
·
Received March 15, 2011
Report
- Report Number
- 8031020-2011-00065
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 25, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICES WILL NOT BE RETURNED. IF THE DEVICE OR ADD'L INFO IS RECEIVED; IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT. ALSO INVOLVED IN THE EVENT IS CAT NO. 703522, PLATE ADAPTER DIST. LAT. FEMUR RIGHT LOT NO. K953115.
Description of Event or Problem · 1
IT WAS REPORTED, UPON REMOVAL OF TARGETING INSTRUMENTS, THE ADAPTER NUT CROSS THREADED IN THE PLATE ADAPTER. NO ACTION WAS NEEDED AS THE PLATE ADAPTER WAS LOOSE ENOUGH TO REMOVE FROM DIGITAL FEMUR PLATE AT CONCLUSION OF THE CASE. THE CASE FINISHED WITHOUT FURTHER ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTER NUT | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | K873154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |