FDA Adverse Event
Other
Summary report: N
MANTIS FIXATION TRAY
MDR report key: 1692224
·
Received May 13, 2010
Report
- Report Number
- 9617544-2010-00214
- Event Type
- Other
- Date Received
- May 13, 2010
- Date of Event
- April 13, 2010
- Report Date
- April 13, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
NURSE (B)(6) REPORTS VIA OUR SALES REP, (B)(4), THAT THE FEET OF THE CONTAINER ARE PUSHING THROUGH THE SOFT WRAPPING WHICH IS PLACED AROUND THE CONTAINERS AFTER STERILIZATION. NURSE (B)(6) REPORTED THAT THOSE CONTAINERS WERE NOT USED IN THEATRE BECAUSE, A LACK OF STERILITY WAS FEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANTIS FIXATION TRAY | INSTRUMENT | LXH | STRYKER SPINE BORDEAUX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |