FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P - US TOBRA FD 10-PK
MDR report key: 1962901
·
Received December 22, 2010
Report
- Report Number
- 9610726-2010-00488
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- K014199
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "4 CASES OF (B)(4) WERE RECEIVED DAMAGED WITH BROKEN VIALS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P - US TOBRA FD 10-PK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | MKR065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |