MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Catalog Number	IFNT511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
Doctor indicated loss of integration, sinus perforation.The implant was removed.Surgical/medical intervention required for permanent damage: no.Additional appointment required: no.Grafted: alloplast placed with implant placement.Tooth site: 3.On a follow up received on (b)(6), 2025, customer responded stating the perforation to sinuses was minimal and was treated with a collagen plug.
Event or Problem Description
Customer responded stating the perforation to sinuses was minimal and was treated with a collagen plug.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative zimvie received one (1) ifnt511, full osseotite tapered certain implant 5 x 11.5mm for evaluation.Visual evaluation was performed.The implant had signs of use with debris on its external threads and markings from removal.There was no damage identified or signs of malfunction that would have contributed to the event.Dhr review was completed for the subject lot number 2022090755.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2022090755 for similar events and no other complaints was identified.Review completed utilizing keywords: dental : functional : loss of integration : perforated sinus.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was likely user caused.Therefore, based on the available information, a device malfunction did not occur.The implant had signs of use.No damage identified or signs of malfunction that would contribute to the event.The reported event was non-verifiable with all the available information provided.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: FULL OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 5 X 11.5MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22071658
• Report Number: 0001038806-2025-01180
• Device Sequence Number: 18482460
• Product Code: DZE
• UDI-Device Identifier: 00844868005063
• UDI-Public: (01)00844868005063(17)270928(10)2022090755
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: Other
• Device Catalogue Number: IFNT511
• Device Lot Number: 2022090755
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic