MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK REG /X ABUT GH 1,5 A 0; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	31024120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
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.
Additional Manufacturer Narrative
Additional information received that this event is about a fractured abutment and not a fractured implant.This is a follow up report for this additional information.Adding udi # (b)(4).This is a follow up report for this additional information.Adding component code 4755 that was missed in the initial submitted report.This is a follow up report for this additional information.Device received for this event is being corrected from unknown ankylos implant catalog # unk ankylos implant to ank reg /x abut gh 1,5 a 0 catalog # 31024120.This is a follow up report for this corrected information.Correcting product code from dze to nha correcting common device name from implant, endosseous, root-form to abutment, implant, dental, endosseous.This is a follow up report for the corrections to this information.
Additional Manufacturer Narrative
B5.Has been corrected in this report.
Event or Problem Description
It was reported that a patient experienced a dental abutment breakage.Customer received repair tools and manual.There is no further information which indicates that the repair attempt failed.

• Brand Name: ANK REG /X ABUT GH 1,5 A 0
• Common Device Name: ABUTMENT, 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: 20663848
• Report Number: 3013111692-2024-34083
• Device Sequence Number: 8207706
• Product Code: NHA
• UDI-Device Identifier: 07392532217401
• UDI-Public: 07392532217401
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/30/2025

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: 31024120
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/15/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown