MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 8.5MM; DENTAL IMPLANT

Catalog Number	XIITP5485
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #3 was removed due to perforated sinus.The patient came back for uncovering of the implant.Implant couldn't be located.Cbct was taken; implant was localized in the posterior maxillary sinus cavity.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).E1: initial reporter¿s title is not provided / unknown.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Zimvie received one (1) xiitp5485, (osseotite® tapered certain® prevail® implant 5/4 x 8.5mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use; however, no apparent malfunction was identified with the implant that would contribute to the reported event.Implant matched prints where measured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2023050142.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 2023050142 for similar events and no other complaint was identified.Review completed utilizing keywords: perforated sinus.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are patient factors and improper techniques.Therefore, based on the available information, a device malfunction did not occur.The reported event was non-verifiable with all the available information.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 8.5MM
• 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: 20548434
• Report Number: 0001038806-2024-02446
• Device Sequence Number: 20725220
• Product Code: DZE
• UDI-Device Identifier: 00844868022190
• UDI-Public: (01)00844868022190(17)280509(10)2023050142
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: Lay User/Patient
• Device Catalogue Number: XIITP5485
• Device Lot Number: 2023050142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic