MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK REG C/ABUT GH 0,75 A 0; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	17-3050
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2023
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: adding additional type of investigation code 10.This is a follow up report to add this.Additional code.Adding additional investigation finding code 3243.This is a follow up report to add this.Additional code.Adding udi # (b)(4).This is a follow up report this information.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 2408.Component code - 887.The correct codes for this complaint are: medical device problem code - 1260.

• Brand Name: ANK REG C/ABUT GH 0,75 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17850600
• Report Number: 3013111692-2023-57064
• Device Sequence Number: 16963559
• Product Code: DZE
• UDI-Device Identifier: 07392532217531
• UDI-Public: 07392532217531
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K083805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 17-3050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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: 31010453 IMPLANT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown