MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 6 X 13MM; DENTAL IMPLANT

Model Number	IFNT613
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that implant went into sinus.It was retrieved and sinus repaired.Another implant was placed.Tooth site # 15.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).
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 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 product was returned but the reported event could not be verified as the exact details of event and patient anatomical conditions were unknown/nonverifiable.Based on the evaluation and dimensional analysis, 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.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 event.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.The device could not be functionally tested for the reported failure/event.Therefore, the reported event could not be recreated.The complaint is not 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.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.

• Brand Name: FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 6 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: 13937871
• Report Number: 0001038806-2022-00447
• Device Sequence Number: 17274062
• Product Code: DZE
• UDI-Device Identifier: 00844868005124
• UDI-Public: (01)00844868005124(17)230323(10)2018031210
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 03/23/2023
• Device Model Number: IFNT613
• Device Catalogue Number: IFNT613
• Device Lot Number: 2018031210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2018
• 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: 81 YR
• Patient Sex: Female