MAUDE Adverse Event Report: ZIMMER DENTAL ABUT TAPERED ONE-PIECE SCR-V 3.5MM 3MM; DENTAL ABUTMENT

Catalog Number	TAC3
Medical Device Problem Codes	Separation Failure (2547); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint (b)(4).
Event or Problem Description
It was reported that the abutment loosened in the patients mouth.The customer tried removing the bundled healing cap from the abutment but it would not loosen, and the abutment ended up loosening from the implant altogether.Procedure was completed with a spare abutment they had in the office to use as a place holder.Has since replaced with new abutment as well.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: expiration date and unique identifier (udi) number.D9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: device code.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.Zimvie received one abutment with the bundled healing cap for evaluation.Visual evaluation was performed, the healing cap was stuck to the abutment.The healing cap would not disengage from the abutment.Unable to confirm loosening with all the available information.Dhr review was completed for the subject lot number.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 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 was excessive loading on abutment/implant assembly and not torqued to specification.Therefore, based on the available information, a device malfunction did occur.The healing cap wouldn¿t disengage from the abutment.The reported event was confirmed.Loosening was non-verifiable with all the available information.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: ABUT TAPERED ONE-PIECE SCR-V 3.5MM 3MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18566267
• Report Number: 0002023141-2024-00133
• Device Sequence Number: 6660918
• Product Code: DZE
• UDI-Device Identifier: 00889024018426
• UDI-Public: (01)00889024018426(17)280403(10)2023031680
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: Health Professional
• Device Catalogue Number: TAC3
• Device Lot Number: 2023031680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/23/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic