MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 13MM; DENTAL IMPLANT

Catalog Number	XIITP5413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that implant was removed due to implant fracture.Tooth site: 3.
Additional Manufacturer Narrative
Zimvie received one (1) xiitp5413, (osseotite® tapered certain® prevail® implant 5/4 x 13mm) for evaluation.Visual evaluation of the as returned device identified the implant with minor signs of use, apparent bone / tissue attached to external threads.A fractured screw fragment was identified stuck inside the implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2017020270.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2017020270 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review the most likely root causes determined from the investigation are excessive torque applied - customer error, or patient factors.Therefore, based on the available information, the implant malfunction did not occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report d1: brand name d4: catalog number g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23838823
• Report Number: 0001038806-2025-03963
• Device Sequence Number: 9607430
• Product Code: DZE
• UDI-Device Identifier: 00844868022176
• UDI-Public: (01)00844868022176(17)220213(10)2017020270
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: Other
• Device Expiration Date: 02/13/2022
• Device Catalogue Number: XIITP5413
• Device Lot Number: 2017020270
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic