MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK REG C/X GINGIVAF. GH 4,5; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	31024016
Medical Device Problem Codes	Failure to Osseointegrate (1863); Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/11/2023
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 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.Correcting (b)(4)to (b)(4).This is a follow up report for this information.Device received for this event is being corrected from ank c/x impl a9.5/d3.5/l9.5 catalog # 17-0543 to ank reg c/x gingivaf.Gh 4.5 catalog # 31024016.This is a follow up report for this information.Correcting concomitant medical products from 31024016 to unknown.

• Brand Name: ANK REG C/X GINGIVAF. GH 4,5
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17928957
• Report Number: 3013111692-2023-57882
• Device Sequence Number: 6401170
• Product Code: DZE
• UDI-Device Identifier: 07392532217333
• UDI-Public: 07392532217333
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/22/2023

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: 31024016
• Device Lot Number: 486030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/09/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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: 31024016
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown