MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® TAPERED IMPLANT 5/4 X 11.5MM; DENTAL IMPLANT

Catalog Number	BOPT5411
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.Product has been received by zimvie and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the inside threads of the implant at tooth site #31 were stripped and they could not get the implant any further into the bone.The implant was removed and a new implant was placed in the same procedure.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.Correction: product return date was updated from 3/5/26 to 3/16/26.The following sections are being reported: b4: date of this report was updated.D9: device 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: 180.H6: investigation conclusions code was added: 4307.H11: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation of the as returned device identified the implant with signs of use and apparent bone/tissue attached to external threads.The implant's internal threads were observed damaged.Additionally, during functional testing with an in-house plug thread gauge verified the implant's inner threads did not engage.Some damage was identified around the implant's platform likely due to the removal process.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.Based on the investigation and risk management file review, the most likely root cause determined from the investigation is incorrect technique used - customer error.Therefore, based on the available information and functional testing, device malfunction did occur.The reported event was confirmed with all the available information.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.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the unique device identifier (udi) number was submitted incorrectly and has been updated from (b)(4).The following sections are being reported: b4: date of this report was updated.D4: unique device identifier (udi) number was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H11: narrative/data was updated.
Event or Problem Description
No additional event information received at the time of this report.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the implant placement date was updated/corrected from (b)(6) 2025 to (b)(6) 2026.The following sections are being reported: b4: date of this report was updated.D6a: implant placement date was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H11: narrative/data was updated.

• Brand Name: T3® TAPERED IMPLANT 5/4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24676458
• Report Number: 0001038806-2026-01579
• Device Sequence Number: 10071345
• Product Code: DZE
• UDI-Device Identifier: 00844868028512
• UDI-Public: (01)00844868028512(17)301006(10)2120038176
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 04/22/2026

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 Catalogue Number: BOPT5411
• Device Lot Number: 2120038176
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2026
• 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; Not provided
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/21/2026; 04/21/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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: 66 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic