FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P WITH TOBRA UNIT PACKFUL DOSE
MDR report key: 1981648
·
Received January 12, 2011
Report
- Report Number
- 9610726-2010-00500
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 17, 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
- NM, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 9610726-2010-499.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "INCIDENT OCCURRED ON (B)(6) 2010. UNABLE TO DETERMINE WHICH PACKET HAIR CAME FROM. WAS NOT NOTICED UNTIL CEMENT WAS MIXED AND PLACED ON THE IMPLANT AND THE BONE SURFACE. HAIR WAS REMOVED AND RETAINED AS EVIDENCE. ALL SCRUB TECHS AND SURGEON WERE GOWNED AND HOODED. THERE WAS NO HAIR EXPOSED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P WITH TOBRA UNIT PACKFUL DOSE | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | MFR027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |