MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	IFNT413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
Event or Problem Description
Doctor indicated implant too tight, not possible to remove and affected the internal hex.The osteotomy was prepared to the length and diameter of the implant but could not be placed deeply enough to reach the bone.Doctor tried to removed it, but it was too tight, consequently doctor had to perform a wider osteotomy to remove the implant successfully.Site was grafted and patient was sent home to heal for future implant placement.Tooth site # 13 (universal).
Additional Manufacturer Narrative
This report is being submitted to report additional information.The product was returned and the reported event (damaged drive feature) was confirmed.However, inability to place event could not be verified as the exact details of event were nonverifiable.Based on the evaluation, 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 actionable trends or corrective actions for the reported events or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the reported lot number for similar events and 1 other complaint was identified.Functional testing was not performed due to the nature of the device and event.However, the reported events couldn't be recreated.The complaint is related to the functional performance of the device.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.Dental implants are designed and manufactured to achieve osseo-integration after placement into the osteotomy using the recommended surgical protocol.The inability to achieve primary stability is a well-documented, previously investigated failure which is currently trended on a monthly basis.Current implant design and manufacturing risk documentation assess unable to place implant into osteotomy as potential failures, ultimately through osseo-integration failure, with adequate controls in place.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for the inability to place implants into osteotomy have not identified any signals indicating potential manufacturing non-conformances impacting primary stability.With no signals indicating a systemic quality issue, no escalation to capa is required.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 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: 12602546
• Report Number: 0001038806-2021-01928
• Device Sequence Number: 17193611
• Product Code: DZE
• UDI-Device Identifier: 00844868005025
• UDI-Public: (01)00844868005025(17)240503(10)2019041308
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: Health Professional
• Device Expiration Date: 05/03/2024
• Device Model Number: IFNT413
• Device Catalogue Number: IFNT413
• Device Lot Number: 2019041308
• 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: 09/20/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 10/09/2021
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2019
• 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: Male