FDA Adverse Event
Malfunction
Summary report: N
SURGICAL SIMPLEX CEMENT
MDR report key: 1491591
·
Received July 29, 2009
Report
- Report Number
- 9610726-2009-00156
- Event Type
- Malfunction
- Date Received
- July 29, 2009
- Date of Event
- July 3, 2009
- Report Date
- July 6, 2009
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- K062553
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NURSE
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
THE CUSTOMER REPORTED THAT DURING THE PREPARATION FOR USE, WHEN THE MATERIAL WAS DELIVERED TO THE OR NURSE, THE INNER BLISTER OF THE PACKAGING SHOWED TO BE NOT SEALED, SO IT WAS NOT STERILE. AT THAT POINT THE NURSE OPENED ANOTHER PACKAGE AND FOUND THAT THE BLISTER CONTAINING THE METHYL METHACRYLATE POWDER WAS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL SIMPLEX CEMENT | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | CGP100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |