MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH HEALING ABUTMENT EV (S) 4MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	68013050
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.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.
Additional Manufacturer Narrative
Additional information received: this case was reported by mistake ¿ it is not reportable.New information from case owner: regarding warranty (b)(4).The case severity needed to be changed to non-serious.The sf (b)(6) information led us to believe there was and implant loss involved.Once we received the paperwork, we realized there was no implant loss involved at all which changes this case to non-serious.Please disregard this report since this is a non-serious event.This is a follow up report for this additional information.Correcting this report from a serious event to a non-serious event.This case was reported by mistake ¿ it is not reportable.New information from case owner: regarding warranty (b)(4).The case severity needed to be changed to non-serious.The sf (b)(6) information led us to believe there was and implant loss involved.Once we received the paperwork, we realized there was no implant loss involved at all which changes this case to non-serious.Please disregard this report since this is a non-serious event.This is a follow up report for this corrected information.

• Brand Name: HEALING ABUTMENT EV (S) 4MM
• 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: 20677944
• Report Number: 3013111692-2024-34433
• Device Sequence Number: 8395384
• Product Code: DZE
• UDI-Device Identifier: 07392532259920
• UDI-Public: 07392532259920
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 68013050
• Device Lot Number: 506117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/28/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown