MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN¿ TITANIUM HEXED SCREW; DENTAL SCREW

Catalog Number	IUNIHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.
Event or Problem Description
It was reported that the screw retained crown has a detachment of the ceramic and has been sent to the prosthetics on (b)(6) 2025.On (b)(6) 2025 x-ray was ok.When screwing manually, the screw fractured.The lower part remained inside the implant.Patient has been sent to another doctor that is specialist removing the fractured screws.Appointment scheduled for (b)(6) 2025.Tooth location 16.Fracture screw was able to be removed from the implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) iuniht, (certain titanium hexed screw) for evaluation.Visual evaluation was performed, a fracture has been identified at the threads.Dhr review was completed for the subject lot number 1282594.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 1282594 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw the customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque applied during placement/ seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the threads.The reported event was 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.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.

• Brand Name: CERTAIN¿ TITANIUM HEXED SCREW
• Common Device Name: DENTAL SCREW
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23334582
• Report Number: 0001038806-2025-02511
• Device Sequence Number: 9948943
• Product Code: NHA
• UDI-Device Identifier: 00844868008545
• UDI-Public: (01)00844868008545(17)290520(10)1282594
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072642
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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 Catalogue Number: IUNIHT
• Device Lot Number: 1282594
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/25/2025
• 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: 10/20/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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: 66 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic