MAUDE Adverse Event Report: ZIMVIE US CORP LLC TWIST HA 3.25MMX10MM; DENTAL IMPLANT

Catalog Number	2130
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant placement procedure, one of the six tines broke off of the implant at tooth site #6.The dentist replaced it with the same product from their inventory.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).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.
Event or Problem Description
The distributor confirmed what the investigation found.The implant fingers are not actually fractured, just bent.
Additional Manufacturer Narrative
This report is being submitted to relay additional information, corrected data and device evaluation.Correction: distributor confirmed what the investigation found.The implant fingers are not actually fractured, just bent.The following sections are being reported: b4: date of this report was updated.B5: event description 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: device code was updated to 1384.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 / functional test was performed, implant shows slight minor signs of use and some of the fingers of the spline implant were identified to be bent.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 was clinician uses device improperly, insufficient training.Therefore, based on the available information, device malfunction did occur.Some of the fingers of the spline implant were identified to be bent.The reported event is 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.

• Brand Name: TWIST HA 3.25MMX10MM
• 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: 24497272
• Report Number: 0001038806-2026-01119
• Device Sequence Number: 20109895
• Product Code: DZE
• UDI-Device Identifier: 00889024013285
• UDI-Public: (01)00889024013285(17)290604(10)2120007281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093164
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 2130
• Device Lot Number: 2120007281
• 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: 03/03/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: 67 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic