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 Codes	Fracture (1260); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Additional information received: adding concomitant medical products implant (b)(6).This is a follow up report for this additional information.Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding additional health effect - impact code: 462.This is a follow up report to add this additional code.Device received for this event is being corrected from ank c/x impl b9.5/d4.5/l9.5 catalog # 17-0553 to ank reg /x abut gh 1,5 a 0 catalog # 31024120.This is a follow up report for this corrected information.Correcting udi# from (b)(4).This is a follow up report for this corrected information.Correcting product code from dze to nha.This is a follow up report for this corrected information.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 1863.Investigation findings code - 3221.The correct codes for this complaint are: medical device problem code - 1260.Investigation findings code - 3252.This is a follow up report for this corrected information.Removing implanted, date (b)(6) 2024.Removing explanted, date (b)(6) 2024.This is a follow up report for this corrected information.

• 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: 20047557
• Report Number: 3013111692-2024-25674
• Device Sequence Number: 12773591
• Product Code: NHA
• UDI-Device Identifier: 07392532217401
• UDI-Public: 07392532217401
• Combination Product (Y/N): N
• Initial Reporter Country: CB
• PMA/510(K) Number: K140347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/12/2024

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: 31024120
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/12/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/12/2024
• 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: IMPLANT 31010428
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown