MAUDE Adverse Event Report: Dentsply Implants Manufacturing GmbH PrimeTaper Drill Sleeve 4ND GS; accessories, implant, dental, endosseous

Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• Brand Name: PrimeTaper Drill Sleeve 4ND GS
• Common Device Name: accessories, implant, dental, endosseous
• Manufacturer (Section D): Dentsply Implants Manufacturing GmbH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: mr. dan eagar; suite 60w; york, PA 17401
• MDR Report Key: 50792309
• Report Number: 3013111692-2026-41249
• Device Sequence Number: 18522940
• Product Code: NDP
• UDI-Device Identifier: 07392532269950
• UDI-Public: 07392532269950
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/16/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown