MAUDE Adverse Event Report: Dentsply IH AB IMPLANT DRIVER (XS) LONG; accessories, implant, dental, endosseous

Catalog Number	68015187
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a tool issue; the implant didn't engage in implant driver.
Additional Manufacturer Narrative
Dentsply sirona became aware of a malfunction for same/similar devices that could have possibly caused or contributed to a serious injury.Product return has been requested and 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.We will continue to track and monitor the trend.

• Brand Name: IMPLANT DRIVER (XS) LONG
• Common Device Name: accessories, implant, dental, endosseous
• Manufacturer (Section D): Dentsply IH AB; aminogatan 1; molndal S-431 21; SW S-431 21
• Manufacturer (Section G): Dentsply IH AB; aminogatan 1; molndal S-431 21; SW S-431 21
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; +1(717)845-7511
• MDR Report Key: 50858614
• Report Number: 9612468-2026-08324
• Device Sequence Number: 9953623
• Product Code: NDP
• UDI-Device Identifier: 07392532254833
• UDI-Public: 07392532254833
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 68015187
• Device Lot Number: 530242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown