FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE SUMEX DRILL
MDR report key: 1813042
·
Received August 12, 2010
Report
- Report Number
- 1811755-2010-00917
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Date of Event
- July 29, 2010
- Report Date
- July 29, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY THE MFR FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION DETAILS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING USE. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE PROCEDURE. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE SUMEX DRILL | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |