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

Catalog Number	31024130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: adding udi # (b)(4).This is a follow up report for this additional information.Device received for this event is being corrected from unknown ankylos abutment catalog # unk ankylos abutment to ank reg /x abut gh 3,0 a 0 catalog # 31024130.This is a follow up report for this corrected information.
Additional Manufacturer Narrative
Therefore, because a serious injury resulted.This event is reportable, per 21 cfr part 803.Section h6 was done, based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product return is requested.And product 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.
Event or Problem Description
It was reported, that a patient experienced a dental implant loss.

• Brand Name: ANK REG /X ABUT GH 3,0 A 0
• 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: 20748109
• Report Number: 3013111692-2024-35362
• Device Sequence Number: 8287335
• Product Code: DZE
• UDI-Device Identifier: 07392532217456
• UDI-Public: 07392532217456
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 31024130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/09/2024
• 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: 1 IMPLANT ANKYLOS B11, REF: 31010430 (ALSO PHY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male