MAUDE Adverse Event Report: BIOMET 3I 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD, 6MM(D) X 6MM(L); DENTAL IMPLANT

Catalog Number	BNES606
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
Event or Problem Description
It was reported that the doctor opened and prepared this implant however, even before use, the encodes did not fit well and it felt tight, so the implant was not used.The size of the hex of this implant is questionable.
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).Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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.D9: device availability and return date were 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 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation and a functional test were performed, the implant had signs of use with markings from removal.The implant engaged and disengaged with the returned abutments.Measurements match drawing.The implant met specifications.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 no other complaint was identified.A definitive root cause could not be determined since device malfunction did not occur.The reported event was unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, device malfunction did not occur.No damage to the implant was identified.The implant met specifications.The reported event was unconfirmed.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, 6MM(D) X 6MM(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: 21356281
• Report Number: 0001038806-2025-00306
• Device Sequence Number: 9078588
• Product Code: DZE
• UDI-Device Identifier: 00844868033622
• UDI-Public: (01)00844868033622(17)280519(10)2023050524
• 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
• 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: Health Professional
• Device Catalogue Number: BNES606
• Device Lot Number: 2023050524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/18/2023
• 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 ABUTMENT-SEE H10 NARRATIVE
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic