MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 5/4 X 10MM; DENTAL IMPLANT

Catalog Number	BNPT5410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that intaglio of implant in damaged, was not restorable by general dentist.Implant removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).B3: date of event unknown / not provided.D6a: implant date unknown / not provided.D6b: explant date unknown / not provided.
Event or Problem Description
It was reported that intaglio of implant in damaged, was not restorable by general dentist.Implant removed.Clinician response to type of damage implant had was that it was hard to specifically say.Both myself and a prosthodontist (dr.----) looked at it.We both found that an encode healing abutment seated just fine/ flush/ engaged the threads, but when the permanent abutment was placed there was rock to it when fully seated (like the deeper threads were damaged or stripped).
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report.B5.Describe event or problem.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.
Additional Manufacturer Narrative
Zimvie received one (1) bnpt5410, (3i t3 with dcd tapered implant 5/4 x 10mm) for evaluation.Visual evaluation was performed, damage to the implant was identified, likely from removal.The drive feature worn however functionally tested with in-house screw and does not thread inside.Dhr review was completed for the subject lot number 2022020818.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 2022020818 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 customer error, applying to much torque/speed during seating.Therefore, based on the available information, a device malfunction did occur.The implant internal threads were damaged.An in-house screw did not thread inside the implant.The reported event was confirmed.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.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 h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: 3I T3 WITH DCD TAPERED 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: 22332878
• Report Number: 0001038806-2025-01502
• Device Sequence Number: 9160391
• Product Code: DZE
• UDI-Device Identifier: 00844868028369
• UDI-Public: (01)00844868028369(17)270309(10)2022020818
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/04/2025

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 Catalogue Number: BNPT5410
• Device Lot Number: 2022020818
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/03/2025
• 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: 06/25/2025
• Supplement Report FDA Received Date: 07/08/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic