MAUDE Adverse Event Report: ZIMMER DENTAL ABUT TAPERED ONE-PIECE SC R-V 4.5MM 2MM; DENTAL SCREW

Catalog Number	TACW2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A4: patient weight unknown / not provided.G4: additional pma/510(k) number k013227.
Event or Problem Description
It was reported that patient came in due to concerns with mobility of upper screw retained denture.Tacw2 fractured.Removed and replaced with new mua's screwed denture back into implants no mobility noted.Patient wears bite splint to protect implants/denture.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report d4: lot number g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie did not receive one (1) tacw2, (abut tapered one-piece sc r-v 4.5mm 2mm) 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).Dhr review was completed for the subject lot number 2020121019.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 2020121019 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 as per rm-00556-haz rev 6, the most likely root cause determined from the investigation was patient factors.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 d4: lot number and udi number: d9: device availability g3: date received by manufacturer g6: checked "follow-up" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: ABUT TAPERED ONE-PIECE SC R-V 4.5MM 2MM
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23144138
• Report Number: 0002023141-2025-02642
• Device Sequence Number: 9812667
• Product Code: DZE
• UDI-Device Identifier: 00889024018464
• UDI-Public: (01)00889024018464(17)260104(10)2020121019
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K011028
• 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,Followup
• Report Date (Section B): 11/04/2025

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 Expiration Date: 01/04/2026
• Device Catalogue Number: TACW2
• Device Lot Number: 2020121019
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/04/2025
• 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; Not provided
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/24/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic