MAUDE Adverse Event Report: ZIMVIE US CORP LLC TITANIUM TEMPORARY ABUTMENT, 2.9MMD PLATFORM, 3.5MMD EMERGENCE PROFILE; DENTAL SCREW

Catalog Number	CTANP31
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the screw fractured at tooth site #10.A provisional restoration was fabricated using an eztetic implant temporary abutment.During hand tightening of the screw to deliver the provisional crown, the screw fractured and the remaining fragment could not be retrieved.The provisional restoration was left in position by bonding it to the adjacent teeth.At this time, retrieval of the remaining portion of the fractured screw is required, and the appropriate tools are needed to perform this procedure.Had to improvise the delivery of the restoration, which was not performed as originally planned, and the treatment is currently on hold until they are able to retrieve the remaining parts of the abutment.Patient will need to return for retrieval of the remaining parts of the abutment in order to proceed with the final restoration.
Additional Manufacturer Narrative
Zimvie did not receive one (1) ctanp31, (titanium temporary abutment, 2.9mmd platform, 3.5mmd emergence profile) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).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 2120027357.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 2120027357 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 cause determined from the investigation is clinician error - excessive torque applied.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.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 g3: date received by manufacturer g6: checked "follow-up" 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: TITANIUM TEMPORARY ABUTMENT, 2.9MMD PLATFORM, 3.5MMD EMERGENCE PROFILE
• Common Device Name: DENTAL SCREW
• 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: 24019478
• Report Number: 0001038806-2026-00163
• Device Sequence Number: 18777939
• Product Code: DZE
• UDI-Device Identifier: 00889024343924
• UDI-Public: (01)00889024343924(17)300206(10)2120027357
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K142082
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: CTANP31
• Device Lot Number: 2120027357
• Was Device Available for Evaluation?: No
• 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: 01/09/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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
• Patient Age: 23 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic