MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSP.PROFILE EV 4.8PS-8MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	25446
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pocket Erosion (2013)
Date of Event	01/17/2024
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.

• Brand Name: OSSEOSP.PROFILE EV 4.8PS-8MM
• 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: 18638722
• Report Number: 3013111692-2024-03563
• Device Sequence Number: 7834586
• Product Code: DZE
• UDI-Device Identifier: 07392532137624
• UDI-Public: 07392532137624
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/05/2024

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: 25446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male