MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK REG C/ABUT GH 3,0 A 7,5; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	17-3071
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that an ank reg c/abut gh 3,0 a 7,5 abutment fractured.Case description is somewhat unclear, but indicates, that the implant remains as sleeper after several failed repair attempts.
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.This mdr submission is a late submission.A capa has been issued.

• Brand Name: ANK REG C/ABUT GH 3,0 A 7,5
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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: 19498352
• Report Number: 3013111692-2024-17105
• Device Sequence Number: 12739472
• Product Code: DZE
• UDI-Device Identifier: 07392532217654
• UDI-Public: 07392532217654
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 17-3071
• Device Lot Number: 20051118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 06/10/2024
• 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: ANK B11 IMPLANT 31010430 - (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown