MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	XIFNT411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the implant at tooth site #11 was removed due to bone loss, lack of primary stability & bone fracture, apical buccal plate perforation occurred during the procedure.Standard osteotomy was performed & implant 4 x 13 was placed with good primary stability.Healing abutment was also placed.Then i noticed some granulation after tissue remaining on apical bone buccal plate & i realized that the bony defect was not completely filled with bone in apical portion of implant.The 3 apical implant screw threads were exposed.I removed implant & attempted placement of 4 x 11.5 but poor stability.So, i just bone graft.
Additional Manufacturer Narrative
Zimvie received one (1) xifnt411, (osseotite tapered certain implant 4 x 11.5mm) for evaluation.Visual evaluation was performed, the implant had minor signs of use with debris on its internal and external threads.There was 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 2020110681.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 2020110681 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz, the most likely root cause determined from the investigation was inadequate treatment planning and patient factors.Refer to attached summary investigation for bone loss and lack of primary stability therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.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.Similar complaints for the inability to achieve primary stability (unable to place implant into osteotomy) 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.While non-conformances were identified for some lots during manufacturing records reviews, the documented disposition actions for each have not suggested the likely release of non-conforming product.To date, all complaint data 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 caused or contributed to the reported event.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".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Based on updated customer information received and reassessment of the reported event, it was determined that mfr report number 0001038806-2025-01955 was reported in error.Please disregard this submission.No further reports will be submitted for this event.The following sections have been updated: b4: date of this report, g3: date received by manufacturer, g6: checked "follow-up", h2: checked follow-up type, h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN IMPLANT 4 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: 22843234
• Report Number: 0001038806-2025-01955
• Device Sequence Number: 4927030
• Product Code: DZE
• UDI-Device Identifier: 00844868021964
• UDI-Public: (01)00844868021964(17)251123(10)2020110681
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/21/2025

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 Expiration Date: 11/23/2025
• Device Catalogue Number: XIFNT411
• Device Lot Number: 2020110681
• Was Device Available for Evaluation?: No
• 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; Not provided
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/09/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic