FDA Adverse Event
Malfunction
Summary report: N
25MM CALCAR BODY/BOLT (+10) COMPONENT LEVEL 9002
MDR report key: 2945096
·
Received December 21, 2012
Report
- Report Number
- 9616680-2012-01484
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K050138
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUPPLEMENTAL UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DOCTOR USED THE MOD-RESTORATION SYSTEM. A SCRUB NURSE OPENED THE ABOVE BODY AND THE LOCKING SCREW STUCK TO THE OUTER STERILE TOP WHEN OPENED RESULTING IN THE BOLT GOING ON THE FLOOR. ANOTHER BODY WAS OPENED TO OBTAIN A +10 MM BOLT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 25MM CALCAR BODY/BOLT (+10) COMPONENT LEVEL 9002 | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | T103271BA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |