FDA Adverse Event
Injury
Summary report: N
SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE
MDR report key: 4961236
·
Received July 29, 2015
Report
- Report Number
- 3007362683-2015-00010
- Event Type
- Injury
- Date Received
- July 29, 2015
- Date of Event
- February 4, 2015
- Report Date
- March 27, 2015
- Manufacturer
- DENTSPLY IMPLANTS N.V.
- Product Code
- EBG
- PMA / PMN Number
- K113739
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THEREFORE, BECAUSE TREATMENT COULD NOT BE COMPLETED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE GUIDE FRACTURE WAS CAUSED BY A COMBINATION OF AN INACCURATE PLASTER MODEL AND POSSIBLE REMOVAL OF TOO MUCH MATERIAL DURING PRODUCTION PROCESS.
Description of Event or Problem · 1
IN THIS CASE, A CUSTOMER PLANNED TO PLACE THREE IMPLANTS BY THE SUPPORT OF A SURGIGUIDE. INTRAOPERATIVELY, THE GUIDE BROKE BETWEEN THE PLANNED IMPLANTS IN REGION #13 AND #14, WHEN THE DENTIST USED THE PUNCH TO REMOVE SOFT TISSUE. THEREFORE, THE DENTIST ABORTED THE SURGICAL TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 492379 | SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE | VARIOUS, EBG, LLZ, DZE | EBG | DENTSPLY IMPLANTS N.V. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |