MAUDE Adverse Event Report: ZIMMER DENTAL CONTOUR ABUTMENT, 2.9MMD PLATFORM, 3.7MMD EMERGENCE PROFILE, 1.5MM CUFF; DENTAL ABUTMENT

Model Number	CANP31S
Medical Device Problem Codes	Separation Failure (2547); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the restoring clinician placed the contour abutment in the patient's mouth and when they tried to remove it, during the same procedure they had a very hard time disengaging the abutment from the implant.Roughly hour delay during procedure.Doctor ended up using pneumatic crown remover and tapping on it multiple times before it came out.
Additional Manufacturer Narrative
Zimview complaint cmp-0866674.A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.E1: initial reporter¿s title and last name are not provided / unknown.D10: unknown dental implant, lot number unknown.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Zimvie received one abutment for evaluation.A visual evaluation and functional test was performed, there was signs of use identified.However, no apparent signs of malfunction.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.A definitive root cause could not be determined.Therefore, based on the available information, a device malfunction did not occur.No damage to the abutment was identified.The reported event was not confirmed.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.Zimvie will continue to monitor for trends.

• Brand Name: CONTOUR ABUTMENT, 2.9MMD PLATFORM, 3.7MMD EMERGENCE PROFILE, 1.5MM CUFF
• 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 ; 5617766700
• MDR Report Key: 16822293
• Report Number: 0002023141-2023-01176
• Device Sequence Number: 6987528
• Product Code: DZE
• UDI-Device Identifier: 00889024343092
• UDI-Public: (01)00889024343092(17)270715(10)2022070503
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142082
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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 Model Number: CANP31S
• Device Catalogue Number: CANP31S
• Device Lot Number: 2022070503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic