FDA Adverse Event
Malfunction
Summary report: N
TRITON ATTACHMENT SAGITTAL SAW
MDR report key: 384538
·
Received March 20, 2002
Report
- Report Number
- 1625507-2002-00032
- Event Type
- Malfunction
- Date Received
- March 20, 2002
- Report Date
- February 17, 2002
- Manufacturer
- MEDTRONIC MIDAS REX
- Product Code
- HBE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHEVRON OSTEOTOMY, THE MICRO SAGITTAL SAW WAS "BOGGING DOWN AND STALLING" CAUSING BURNING OF THE BONE AND SUBSEQUENT SLOWER THAN USUAL HEALING. NO ADD'L PT F/U INFO WAS OBTAINABLE FROM THE DOCTOR OF THE HOSPITAL PERSONNEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRITON ATTACHMENT SAGITTAL SAW | PNEUMATIC SURGICAL DRILL ATTACHMENT | HBE | MEDTRONIC MIDAS REX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |