MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSP.PROFILEEV 4.2PS-11MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	25442
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Osteolysis (2377)
Date of Event	08/29/2025
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 and further information is requested and product will be evaluated after receipt.Should additional information become available, a follow-up report will be submitted.
Event or Problem Description
It was reported that a patient experienced a dental implant fracture and the implant was removed.
Additional Manufacturer Narrative
Additional fda coding being added after investigation of device.Adding additional health effect - clinical code: 2377.This is a follow up report to add this additional code.Device received for this event is being corrected from unknown atis ev implant catalog # unk atis ev implant to osseosp.Profileev 4.2ps-11mm catalog # 25442.This is a follow up report for this corrected information.Correcting lot # from unk to 413735.This is a follow up report for this corrected information.Correcting udi # from ni to udi # (b)(4).This is a follow up report for this corrected information.

• Brand Name: OSSEOSP.PROFILEEV 4.2PS-11MM
• 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: 23201186
• Report Number: 3013111692-2025-28758
• Device Sequence Number: 21329377
• Product Code: DZE
• UDI-Device Identifier: 07392532137587
• UDI-Public: 07392532137587
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 25442
• Device Lot Number: 413735
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/10/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown