MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Catalog Number	XIFNT3213
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.B3: date of event unknown / not provided.Product has been received by zimvie and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient came in for un-covery of a different implant.The patient was having pain with the implant at tooth site #6.The implant was loose and once removed and an x-ray was taken, we discovered that the implant had fractured.Bone loss was also reported.Symptoms as a result of the event: pain.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307 and 4310 h11: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, and was observed attached to a locator abutment.The implant was seen fractured at the apex region.Functional testing to recreate the reported events could not be performed due to the nature of the device & events.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is parafunctional habits/patient factors.A summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost non-existent.Therefore, based on the available information, implant malfunction did occur.The reported event (fracture implant) was confirmed with all the available information.Bone loss is a medical condition and is non-verifiable with the information provided.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 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: 24394494
• Report Number: 0001038806-2026-00893
• Device Sequence Number: 9862322
• Product Code: DZE
• UDI-Device Identifier: 00844868021902
• UDI-Public: (01)00844868021902(17)260521(10)2021050263
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/21/2026
• Device Catalogue Number: XIFNT3213
• Device Lot Number: 2021050263
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic