MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ PREVAIL¿ IMPLANT 6/5 X 10MM; DENTAL IMPLANT

Catalog Number	XIITP6510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Osteolysis (2377)
Date of Event	10/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has been on xgena (bisphosnates), possibly the cause of failure (necrotic bone).Per indicated: symptoms as a result of the event: bone loss/necrotic bone surgical/medical intervention required for permanent damage: implant removed.Additional appointment required: cbct 6 months.Was the procedure completed using another implant or another device? no.Site grafted: mineross, on (b)(6) 2024.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(6).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-conformance's 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.H3 other text: summary investigation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) xiitp6510, (osseotite® tapered certain® prevail® implant 6/5 x 10mm) for evaluation.Visual evaluation was performed.The implant had signs of use with bone debris on its external threads.No damage identified or signs of malfunction that would have contributed to the event.Measurements match drawing.Dhr review was completed for the subject lot number 2021060918.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 2021060918 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : other.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction has not occurred.No damage to the implant was identified that would cause or contribute to the event.The reported event 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 6/5 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: 20714940
• Report Number: 0001038806-2024-02685
• Device Sequence Number: 9604384
• Product Code: DZE
• UDI-Device Identifier: 00844868022206
• UDI-Public: (01)00844868022206(17)260716(10)2021060918
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 07/15/2026
• Device Catalogue Number: XIITP6510
• Device Lot Number: 2021060918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2024
• 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: 11/18/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic