FDA Adverse Event
Death
Summary report: N
SIMPLEX P-JAPANESE TWIN PACK
MDR report key: 1163050
·
Received September 16, 2008
Report
- Report Number
- 9610726-2008-00063
- Event Type
- Death
- Date Received
- September 16, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 22, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- N17004
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, THE PT'S BLOOD PRESSURE SUDDENLY DROPPED AND PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P-JAPANESE TWIN PACK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |