FDA Adverse Event
Malfunction
Summary report: N
MANTIS CANNULATED MODULAR AWL
MDR report key: 1496378
·
Received August 27, 2009
Report
- Report Number
- 9617544-2009-00374
- Event Type
- Malfunction
- Date Received
- August 27, 2009
- Date of Event
- August 13, 2009
- Report Date
- August 19, 2009
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- HWJ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
DOCTOR REPORTED VIA OUR SALES REP, THAT HE NOTED AFTER A SURGERY PROCEDURE, THAT THE TIP IS BROKEN OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANTIS CANNULATED MODULAR AWL | INSTRUMENT | HWJ | STRYKER SPINE BORDEAUX | NA | 073629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |