FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2082554
·
Received April 28, 2011
Report
- Report Number
- 1811755-2011-01488
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 31, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS AVAILABLE FOR EVAL BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFO WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE MICRO SAGITTAL SAW WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING TESTING. THE EVENT OCCURRED DURING ROUTINE MAINTENANCE VISIT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |