Glidewell HT Implant Driver
Received Jul 27, 2026 · Event occurred Apr 16, 2026
Report 3011649314-2026-01159 · MDR key 50018500
Device
Generic name
Glidewell Ht Implant Driver
Manufacturer
Prismatik Dentalcraft, Inc.Product problems
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported on 04/17/2026, that Dr. (b)(6) stated that during an implant placement, the implant driver tip fractured and stuck inside of an implant, 4.3 x13 mmL. "Nothing defected but fractured driver during" implant placement. Additional information received reported that the event occurred on 04/16/2026. There was no issue with the implant device and the 52-year-old, male patient did not suffer any injury or adverse outcome and no medical intervention was required. The lot number of the driver is unknown but the driver was returned to Glidewell.
Additional Manufacturer Narrative
The reported device has not yet been received for investigation. An investigation will be carried out and a supplemental report will be submitted upon completion of the investigation. Manufacturer Reference#: (b)(4).