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	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per indicated: the mount won't come off.The implant mount was too hard and could not be removed.Therefore, the doctor removed it and replaced it with a different product.Tooth site # 30.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age and date of birth unknown / not provided.A4: patient weight unknown / not provided.
Additional Manufacturer Narrative
Zimvie received one (1) bnes505, 3i t3 short external hex parallel walled implant with dcd, 5mm(d) x 5mm(l) for evaluation.Visual and functional evaluation was performed.The returned implant and bundle mount have signs of use, and apparent bone / tissue was seen attached to the implant's external threads.During a functional / physical test the abutment did not disengage/release from the implant as intended.Some damage was seen on the abutment's collar likely due to the removal process.Dhr review was completed for the subject lot number 2019080043.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 2019080043 for similar events and no other complaint was identified.The customer did submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz rev 13, the most likely root cause determined from the investigation was probably user caused.Therefore, based on the available information, a device malfunction did occur.During a functional / physical test the abutment did not disengage/release from the implant as intended.The reported even was confirmed.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.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.D9: device availability.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.
Event or Problem Description
No further event information available 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: 23052084
• Report Number: 0001038806-2025-02157
• Device Sequence Number: 9824966
• Product Code: DZE
• UDI-Device Identifier: 00844868033592
• UDI-Public: (01)00844868033592(17)241001(10)2019080043
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: Other
• Device Expiration Date: 10/01/2024
• Device Catalogue Number: BNES505
• Device Lot Number: 2019080043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic