MAUDE Adverse Event Report: BIOMET 3I 3I T3¿ TAPERED IMPLANT 5/4 X 13MM; DENTAL IMPLANT

Model Number	BOPT5413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Paresthesia (4421)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor indicated nerve injury.There had been an extraction of 36 some 2 weeks before, when removal of 46 became necessary.Suggested placement of immediate implant 46 site and early implant 36 site.Tooth site # 36.Paresthesia was reported as a symptom.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Patient weight is not provided / unknown.Initial reporter¿s title is not provided / unknown.
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: type of investigation; h6: investigation findings; h6: investigation conclusions; h10: additional narratives/data.The reported product was returned.The reported event could not be verified as the exact details of event and patient conditions were unverifiable.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing actionable trend or non-conformance / capa / hhe / d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.Zimvie 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 specifications and conforming when it left zimvie.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization records were reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.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.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.

• Brand Name: 3I T3¿ TAPERED IMPLANT 5/4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15566049
• Report Number: 0001038806-2022-01533
• Device Sequence Number: 5959419
• Product Code: DZE
• UDI-Device Identifier: 00844868029830
• UDI-Public: (01)00844868029830(17)231120(10)2018110019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/20/2023
• Device Model Number: BOPT5413
• Device Catalogue Number: BOPT5413
• Device Lot Number: 2018110019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2018
• 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 Age: 68 YR
• Patient Sex: Female