MAUDE Adverse Event Report: ZIMMER DENTAL 15 DEG TAPER,3.5P 2MM-3MM; DENTAL ABUTMENT

Catalog Number	15AT323
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported abutment loosening+ screw deformed when try to tight.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.The abutment loosening was found, leading to the screw deformed.The force could not be applied and locked tightly, leading to the failure.The implant was then removed.The corresponding number was tsv4b11.The batch number was 63850943.Tooth site # 44-45.
Additional Manufacturer Narrative
Zimvie received one (1) 15at323, (15 deg taper,3.5p 2mm-3mm) for evaluation.Visual evaluation was performed, the screw threads did not appear to be damage.During a functional / physical test, the abutment screwed into an in-house zimmer implant as intended.This complaint refers to the specific device 15at323.Dhr review was completed for the subject lot number 63873012.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 63873012 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: loosening.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00428-haz, 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.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.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 available at the time of this report.

• Brand Name: 15 DEG TAPER,3.5P 2MM-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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18588299
• Report Number: 0002023141-2024-00171
• Device Sequence Number: 7031309
• Product Code: NHA
• UDI-Device Identifier: 00889024012042
• UDI-Public: (01)00889024012042(17)221130(10)63873012
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 15AT323
• Device Lot Number: 63873012
• 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: 01/26/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic