MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH HEX DRIVER 24MM; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	68015205
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because the event might have led to a serious injury this event is reportable per 21 cfr part 803.The product involved was investigated and no failure was detected.It was concluded, that an incorrect user handling had led to the event.Trend is tracked and monitored.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Event or Problem Description
Hex driver did not hold in ratchet insert during removal of the temp base; this caused the patient to aspirate the driver and expelled it after coughing fit.
Additional Manufacturer Narrative
This device is correct this event from an implant loss event to a hex driver separation event.Corrected data is completed in this follow-up.

• Brand Name: HEX DRIVER 24MM
• 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: 20180869
• Report Number: 3013111692-2024-27539
• Device Sequence Number: 15627241
• Product Code: NDP
• UDI-Device Identifier: 07392532261442
• UDI-Public: 07392532261442
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 68015205
• Device Lot Number: 520457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SURGICAL DRIVER HANDLE 25775, LOT 180322.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown