MAUDE Adverse Event Report: ZIMVIE US CORP LLC GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, CERTAIN® ENGAGING, 4.1MMD X 1.3MMCH; DENTAL TIBASE

Catalog Number	ZFX11ZB-CE41AS13E
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported constant screw loosening at tooth site 37.A new screw was placed.This report refers to first loosening.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie did not receive one (1) item zfx11zb-ce41as13e, for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, and risk management file (rmf).Complaint history review was performed for the reported lot number 0000250801 for similar events and one other complaint was identified.Review completed utilizing keywords: ¿loosening¿.The second complaint is from the same customer and same dent and is made because the screw was lost a second time.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning, misunderstood or overlooked instructions for use.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.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: GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, CERTAIN® ENGAGING, 4.1MMD X 1.3MMCH
• Common Device Name: DENTAL TIBASE
• 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: 24003586
• Report Number: 0001038806-2026-00114
• Device Sequence Number: 16051853
• Product Code: NHA
• UDI-Device Identifier: 04251881714364
• UDI-Public: (01)04251881714364(10)0000250801(240)ZFX11ZB-CE41AS13E
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K231915
• 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): 03/16/2026

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: ZFX11ZB-CE41AS13E
• Device Lot Number: 0000250801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 01/08/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic