FDA Adverse Event
Malfunction
Summary report: N
MED HOWMEDICA BONE PLUG 1PK
MDR report key: 2417482
·
Received January 10, 2012
Report
- Report Number
- 9616680-2012-00021
- Event Type
- Malfunction
- Date Received
- January 10, 2012
- Date of Event
- December 20, 2011
- Report Date
- December 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZN
- PMA / PMN Number
- K951860
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
ARTISAN BONE PLUG WAS OPENED, BELOW THE FIRST COIL COVER THERE WAS A HAIR (BETWEEN BOTH STERILE CONTAINERS). HAIR IS ATTACHED IN THE GLUE OF THE LID AND IS STILL PRESENT. THE NEXT STERILE CONTAINER WITHIN THIS CONTAINER WAS OPENED AND USED, AS PER SURGEONS REQUEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED HOWMEDICA BONE PLUG 1PK | IMPLANT | LZN | STRYKER ORTHOPAEDICS CORK | NA | CPPLF08B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |