FDA Adverse Event
Injury
Summary report: N
XIVE TREPHINE DRILL
MDR report key: 1081747
·
Received July 25, 2008
Report
- Report Number
- 1721411-2008-00065
- Event Type
- Injury
- Date Received
- July 25, 2008
- Report Date
- June 25, 2008
- Manufacturer
- DENTSPLY FRIADENT GMBH
- Product Code
- DZE
- PMA / PMN Number
- K021318
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED IN THIS CASE, THIS EVENT STILL MEETS THE CRITERIA FOR REPORTABILITY BECAUSE A SECOND, UNPLANNED SURGERY WAS REQUIRED TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE AND ACHIEVE THE DESIRED RESULTS. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DOCTOR USED A TREPHINE DRILL TOO LARGE FOR THE IMPLANT BEING PLACED, NECESSITATING A SECOND SURGERY USING A DIFFERENT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIVE TREPHINE DRILL | DZE | DENTSPLY FRIADENT GMBH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | XIVE TREPHINE DRILL D4.5 |