MAUDE Adverse Event Report: ZIMMER DENTAL ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM; DENTAL ABUTMENT

Catalog Number	TAC2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.G4: premarket identification k013227.
Event or Problem Description
The doctor reports a fracture of the screw of the multi-unit abutment inside the implant, which could not be removed using the rescue kit.Implant was removed.Tooth position 46.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) tac2, (abut tapered one-piece scr-v 3.5mm 2mm) for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use.The abutment was observed fractured at the threads.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 2023021058.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 2023021058 for similar events and one (1) other complaint was identified.Review completed utilizing keywords: ¿fracture screw¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation is parafunctional habits/patient factors.Therefore, based on the available information, a device malfunction did 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM
• Common Device Name: DENTAL ABUTMENT
• 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: 22837232
• Report Number: 0002023141-2025-02265
• Device Sequence Number: 18453417
• Product Code: DZE
• UDI-Device Identifier: 00889024018419
• UDI-Public: (01)00889024018419(17)280223(10)2023021058
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: TAC2
• Device Lot Number: 2023021058
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2025
• 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: 08/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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: 58 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic