MAUDE Adverse Event Report: ZIMMER DENTAL EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH

Model Number	CT318
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
It was reported that the cover screw got locked on the implant and couldn't be removed, which resulted in the implant being removed.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.One (1) eztetic dental implant, 3.1mm diameter, 2.9mmd platform, 8mm length (ct318) was returned for investigation.Visual evaluation of the as returned product identified the implant with signs of use, damaged external threads from the removal process.Implant measured with caliper and dimensions are correct.Based on the evaluation, and functional testing, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specification and conforming when it left zimmer biomet.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number (1256880) for similar events and no other complaint was identified.Functional testing to recreate the reported event; verified the cover screw was unable to be removed.A definitive root cause could not be identified.However, based on the investigation, ifu and risk file review, the most likely cause determined from the investigation is customer uses inappropriate surgical or restorative protocol resulting in implant being placed or restored contrary to the instructions for use and leads implant breakage.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.

• Brand Name: EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 8MM LENGTH
• Common Device Name: DENTAL IMPLANT
• 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: 15596526
• Report Number: 0002023141-2022-02562
• Device Sequence Number: 14018937
• Product Code: DZE
• UDI-Device Identifier: 00889024343917
• UDI-Public: (01)00889024343917(17)270802(10)1256880
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: Health Professional
• Device Model Number: CT318
• Device Catalogue Number: CT318
• Device Lot Number: 1256880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown