FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE
MDR report key: 2212169
·
Received July 8, 2011
Report
- Report Number
- 9610726-2011-00242
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 22, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- K014199
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "HOSPITAL ORDERED 13 CASES OF TOBRA BONE CEMENT IN (B)(6) 2010. WHEN THE SHIPMENT ARRIVED, THE HOSPITAL NOTICED A FOUL ODOR. THEY SEARCHED THE SHIPMENT, BUT COULD NOT PINPOINT THE UNIT THAT CONTAINED THE BROKEN VIAL. IT WAS NOT UNTIL THE WEEK OF (B)(6) 2011 WHEN THE DAMAGED DOSE WAS DISCOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | MLR073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |