FDA Adverse Event
Malfunction
Summary report: N
BONESOURCE, 2.5G PACK
MDR report key: 2020483
·
Received February 16, 2011
Report
- Report Number
- 9610726-2011-00037
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- December 15, 2010
- Report Date
- February 2, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- MQV
- PMA / PMN Number
- K031435
- Removal / Correction Number
- N
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
SALES REP REPORTED THAT THE BONESOURCE CEMENT SET TOO QUICKLY, MAKING SURGEON UNABLE TO INJECT THE CEMENT INTO THE PT THAT WAS ANAESTHETISED, AND LYING ON THE TABLE. SALES REP FURTHER REPORTED THAT THE CEMENT WENT DRY AND POWDERY WITHIN SECONDS OF MIXING, MAKING SURGEON UNABLE TO INJECT. SALES REP FURTHER ADDED THAT THERE WERE OTHER CEMENTS AVAILABLE. SALES REP THEN ADDED THAT THERE WERE NO DELAYS TO THE SURGERY AND NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONESOURCE, 2.5G PACK | IMPLANT | MQV | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |