Glidewell HT Implant Driver Ø3.5/4.3 Long
Received Jul 29, 2026
Report 3011649314-2026-01154 · MDR key 50070369
Device
Generic name
Glidewell Ht Implant Driver
Manufacturer
Prismatik Dentalcraft, Inc.Model number
70-1071-SRG0298Catalog number
70-1071-SRG0298
Product problems
- Osseointegration Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
On (b)(6) 2026, Dr. (b)(6) reported that the (b)(6) office encountered an issue with the Driver Ø3.5/4.3 Long and Driver Ø3.5/4.3 Short. The doctor confirmed that while removing a 4.3 x 10 implant, the Driver Ø3.5/4.3 Long was used, and while removing a 3.5 x 10 implant, the Driver Ø3.5/4.3 Short was used. The tips of both drivers became stuck inside the implants and fractured. The doctor confirmed that there were no issues with the implants. Additionally, the doctor mentioned that they have not experienced any issues with the drivers from the old surgical kit, and that the old drivers fit the implants perfectly.
Additional Manufacturer Narrative
The device has not been returned for analysis. Complaint history and product history records were reviewed, and documentation indicated the product met release criteria. Once an investigation is completed and a supplemental report will be submitted. Manufacturer internal reference number: (b)(4).