MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH UDKRP32 DRILLKEY RP 3.2; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	54500173
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a tool malfunction where the drill key did not fit properly into the guide.The drill key was stiff and wouldn't go in all the way to the base causing the implant placement to be slightly shallower than typical.The session completed successfully.
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.Products return is requested and they 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.

• Brand Name: UDKRP32 DRILLKEY RP 3.2
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 25593697
• Report Number: 3013111692-2026-19622
• Device Sequence Number: 17567869
• Product Code: NDP
• UDI-Device Identifier: 07392532201820
• UDI-Public: 07392532201820
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 54500173
• Device Lot Number: 10410933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown