FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW, FULLY THREADED 5X30 MM
MDR report key: 2034932
·
Received March 1, 2011
Report
- Report Number
- 9610622-2011-00090
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 7, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K010801
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. PACKAGING WAS DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED, IT CAME TO OUR ATTENTION THIS ITEM WAS USED IN SURGERY ON (B)(6) 2011. ITEM 1896-5030S, LOT# K621878 DID EXPIRE ON 31-JAN-2011. THIS ITEM WAS CYCLE COUNTED OUT OF ORACLE IN (B)(6) 2010. THE REASON FOR BEING CYCLE COUNTED OUT WAS DUE TO THE FACT THAT AFTER 3 ATTEMPTS WE WERE NOT ABLE TO LOCATE THIS ITEM AT THE CONSIGNED HOSPITAL, (B)(6). NO OTHER OBSERVATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW, FULLY THREADED 5X30 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K621878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |