MAUDE Adverse Event Report: ZIMMER DENTAL 30 DEG TAPER 3.5P 4MM-6MM; DENTAL ABUTMENT

Catalog Number	30AT346
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Abutment loosening was reported.Several implants were implanted on (b)(6), 2022.The immediate loading was performed in the afternoon.The restoration was delivered.There was no adverse reactions after surgery.The patient came for re-examination on (b)(6), 2023, and the abutment loosening was found, leading to the deformation of screw.The force could not be applied to lock tightly, causing the failure.The implant was then removed.Tooth site # 24-35.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.D10: tsv4b11, imp, tsv, 4.1mm, sbm, 11.5, lot number 62850943.E1: initial reporter¿s title is not provided / unknown.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Multiple reports are being submitted for this event.Zimvie received one abutment for evaluation.Visual evaluation was performed, minor signs of use and no damaged evaluated.Functional test completed and performed as intended.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 1 other relevant complaint(s) 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 was abutment screw is not torqued to specification.Therefore, based on the available information, a device malfunction did not occur, however the reported event (loosening) is non-verifiable.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.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: 30 DEG TAPER 3.5P 4MM-6MM
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18129582
• Report Number: 0002023141-2023-03220
• Device Sequence Number: 6703292
• Product Code: NHA
• UDI-Device Identifier: 00889024013582
• UDI-Public: (01)00889024013582(17)221130(10)63869699
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111853
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: Lay User/Patient
• Device Expiration Date: 11/29/2022
• Device Catalogue Number: 30AT346
• Device Lot Number: 63869699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/14/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic