FDA Adverse Event
Malfunction
Summary report: N
IMPLANT DRIVER EV (M) LONG
MDR report key: 23822286
·
Received December 16, 2025
Report
- Report Number
- 9612468-2025-02449
- Event Type
- Malfunction
- Date Received
- December 16, 2025
- Date of Event
- November 21, 2025
- Report Date
- December 16, 2025
- Manufacturer
- DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
- Product Code
- NDP
- UDI-DI
- 07392532254871
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DENTSPLY SIRONA BECAME AWARE OF A MALFUNCTION FOR SAME/SIMILAR DEVICES THAT COULD HAVE POSSIBLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. PRODUCT RETURN IS REQUESTED AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.
Description of Event or Problem · 0
IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21 CFR PART 803.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2257566 | IMPLANT DRIVER EV (M) LONG | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | NDP | DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) | 07392532254871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |