MAUDE Adverse Event Report: BIOMET 3I 3I T3 NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 15MM; DENTAL IMPLANT

Catalog Number	BOST415
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that the implant, at the time of placement, broke at the head and will not be returned as it was discarded along with the material.The doctor indicates in the report that there was no negative impact on the patient's health.The affected dental position is unknown: not reported.Type of bone: unknown.Procedure concluded with the placement of another implant.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A4: patient weight unknown: not provided.D4: additional device information unknown: not provided.D4: unique identifier (udi) number not available.D9: device availability unknown: not provided.E1: reporter name and email address unknown: not provided.H4: device manufacturer date unknown: not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie did not receive one (1) bost415, (3i t3 non-platform switched tapered implant 4 x 15mm) 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).Dhr review was completed for the subject lot number 2023050550.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 2023050550 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : implant.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was material selection of the implant was not adequate to with stand recommended torque values for placement/seating.Therefore, based on the available information, a device malfunction was not verified.Without device receipt, the reported event is 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.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.Product not completed.

• Brand Name: 3I T3 NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 15MM
• 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: 18865336
• Report Number: 0001038806-2024-00408
• Device Sequence Number: 19661696
• Product Code: DZE
• UDI-Device Identifier: 00844868028956
• UDI-Public: (01)00844868028956(17)280524(10)2023050550
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: BOST415
• Device Lot Number: 2023050550
• 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: 03/08/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic