FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 1162265
·
Received September 4, 2008
Report
- Report Number
- 1811755-2008-00049
- Event Type
- Malfunction
- Date Received
- September 4, 2008
- Date of Event
- August 6, 2008
- Report Date
- September 3, 2008
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZI
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HAND PIECE WAS RECEIVED AND INSPECTED. THE BUR GUARD WAS MELTED ON THE NOSE CONE OF THE HAND PIECE. THIS CAN OCCUR WHEN THE BUR GUARD IS PUSHED TOO FAR UP ONTO THE HAND PIECE AND THE FRICTION FROM THE NOSE CONE CAN CAUSE THE BUR GUARD TO MELT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ORAL PROCEDURE, A PATIENT RECEIVED A MINOR BURN TO THE LIP, NO ADDITIONAL TREATMENT WAS ADMINISTERED. ACCORDING TO THE DOCTOR, THE BURN HAD HEALED AS OF THE POST-OP APPOINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE IMPACTION DRILL | CORE SYSTEM | DZI | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |