MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 10MM; DENTAL IMPLANT

Catalog Number	XIITP5410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #18 was removed due to bone loss.Pt had implant restored last year early 2023.She was functioning well but developed pain and saw her go yesterday - noted a loose implant and removed the implant per indicated: surgical/medical intervention required for permanent damage: no.Additional appointment required: yes, debride #18 edentulous bone and future implant replaced.Symptoms as a result of the event: none.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.A summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Additional Manufacturer Narrative
Similar complaints for bone loss related problems have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.Furthermore, the probability of manufacturing or design defects that might lead to bone loss escaping the available detections is remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.The dhr was requested, however an electronic copy is not available for review.The investigation will be reopened and updated upon any new or additional information provided to this complaint.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number 2021050253 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿bone loss.¿ as documented in the summary investigation, contributing factors for the reported event likely exist outside of zimvie control, including those related to medical conditions / patient habits and surgical technique.Based on the summary investigation, no malfunction occurred upon investigation and no association between the dental implant and bone loss was found that can explain these events.Therefore, the reported event remains non-verifiable as it is a medical condition.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for bone loss problems reported in association with implant failure have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Therefore, escalation to capa is not required.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.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up." h6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 5/4 X 10MM
• 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: 20794343
• Report Number: 0001038806-2024-02760
• Device Sequence Number: 7810084
• Product Code: DZE
• UDI-Device Identifier: 00844868022152
• UDI-Public: (01)00844868022152(17)260519(10)2021050253
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Expiration Date: 05/18/2026
• Device Catalogue Number: XIITP5410
• Device Lot Number: 2021050253
• 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: 11/27/2024
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2021
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic