MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 11.5MM; DENTALIMPLANT

Model Number	IFNT411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant on tooth site #11 was removed due to a sinus perforation.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.
Event or Problem Description
Upon follow up, the patient identifier was provided by the doctor.
Event or Problem Description
No additional event information was received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: one (1) full osseotite tapered certain implant 4 x 11.5mm (ifnt411) was returned for investigation.Visual evaluation of the as returned product identified signs of use.Device was measured with a caliper and matched print specifications.No malfunctions detected that could lead to the reported event.The reported device was returned but the reported event could not be verified as the exact details of event and patient conditions were unknown/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 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 event or device.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 (2021030860).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, 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.Complaint history review was performed for the reported lot number (2021030860) for similar events and no other complaint was identified.The device could not be functionally tested for the reported failure/event (perforated sinus).Therefore, the reported event could not be recreated.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely cause determined from the investigation is improper techniques used during placement ¿ inadequate treatment planning, selection of implant too long for the depth of osteotomy prepared and patient condition (poor bone density).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: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 11.5MM
• Common Device Name: DENTALIMPLANT
• 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: 15763207
• Report Number: 0001038806-2022-01714
• Device Sequence Number: 18199983
• Product Code: DZE
• UDI-Device Identifier: 00844868005018
• UDI-Public: (01)00844868005018(17)260329(10)2021030860
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2023

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: Health Professional
• Device Expiration Date: 03/29/2026
• Device Model Number: IFNT411
• Device Catalogue Number: IFNT411
• Device Lot Number: 2021030860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 11/15/2022; 03/03/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/14/2022; 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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