FDA Adverse Event
Injury
Summary report: N
MANTIS CANNULATED MODULAR AWL
MDR report key: 1412441
·
Received July 7, 2009
Report
- Report Number
- 9617544-2009-00290
- Event Type
- Injury
- Date Received
- July 7, 2009
- Date of Event
- June 10, 2009
- Report Date
- June 23, 2009
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- HWJ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "TIP OF MANTIS AWL BROKE, PIECES REMOVED FROM PT. NO HARM DONE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANTIS CANNULATED MODULAR AWL | INSTRUMENT | HWJ | STRYKER SPINE BORDEAUX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |