MAUDE Adverse Event Report: BIOMET 3I 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD, 5MM(D) X 5MM(L); DENTAL IMPLANT

Catalog Number	BNES505
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: eha444, bellatek encode healing abutment 4.1mm(d) x 4.1mm(p) x 4mm(h).D10: eha446, bellatek encode healing abutment 4.1mm(d) x 4.1mm(p) x 6mm(h).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that after placing the implant, the doctor discovered that the healing abutment was very hard to place and floated when placed.The same thing happened with a second healing abutment.It is very hard and difficult to work with in the back teeth area.The implant is not available as it has already been implanted.The diameter of the hex of the implant seems to be large.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111, 4114 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.Zimvie did not receive the reported implant 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.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 for similar events and 1 other relevant complaint was identified.Based on the investigation and all available information, a definitive root cause could not be determined.However, adherence to the tapping procedure is critical.This step ensures proper implant seating, reduces the required torque, and helps prevent potential damage to the connection, thereby supporting successful placement.Therefore, based on all the available information, device malfunction was not established.Without device receipt, 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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD, 5MM(D) X 5MM(L)
• 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: 21356091
• Report Number: 0001038806-2025-00305
• Device Sequence Number: 20754394
• Product Code: DZE
• UDI-Device Identifier: 00844868033592
• UDI-Public: (01)00844868033592(17)280531(10)2023050886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150571
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: BNES505
• Device Lot Number: 2023050886
• Was Device Available for Evaluation?: No
• 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: 02/11/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL HEALING ABUTMENT-SEE H10 NARRATIVE.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic