MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRIALIT PLUS IMPL D4,5/L8; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	36-2450
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2019
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.

• Brand Name: FRIALIT PLUS IMPL D4,5/L8
• 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: 19840885
• Report Number: 3013111692-2024-21823
• Device Sequence Number: 7769599
• Product Code: DZE
• UDI-Device Identifier: EFRI323624502
• UDI-Public: EFRI323624502
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 36-2450
• Device Lot Number: B180014445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown