MAUDE Adverse Event Report: BIOMET 3I 3I T3 NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 10MM; DENTAL IMPLANT

Catalog Number	BOSS410
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that the implant at tooth site #unk was removed due to bone loss & allergic reaction.Within weeks of placement gingival swelling with pain occurred.Patient was examined and sutures were removed.Patient then called with cc that implant was protruding from the gingiva.Findings were that bone was gone so implant was removed.Symptoms as a result of the event: pain & swelling.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie did not receive one (1) boss410, (3i t3® non-platform switched parallel walled implant 4 x 10mm) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Functional testing to recreate the reported events could not be performed due to the nature of the device & events.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2120001329.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120001329 for similar events and one (1) other complaint was identified (b)(4).Review completed utilizing keywords: ¿bone loss¿ & ¿allergic reaction¿.The customer did not submit images for the reported events.Based on the investigation and risk management file review as per rmf rm-00053-haz rev.12, the most likely root causes determined from the investigation are customer error and patient factors (material selection.) refer to attached summary investigation for ¿bone loss¿.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported events are non-verifiable.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.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.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 g3: date received by manufacturer g6: checked "follow-up" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: 3I T3 NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 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: 21293459
• Report Number: 0001038806-2025-00250
• Device Sequence Number: 15752762
• Product Code: DZE
• UDI-Device Identifier: 00844868028819
• UDI-Public: (01)00844868028819(17)280821(10)2120001329
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: BOSS410
• Device Lot Number: 2120001329
• Was Device Available for Evaluation?: No
• 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: 02/03/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic