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)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
Doctor reported screw loosening at tooth site 46.Procedure was completed and a new screw was placed.Screw placed on (b)(6) 2023 and removed on (b)(6) 2025.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information lot number updated to unknown.D4: additional device information udi number updated to unknown.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date updated to unknown.H6: adverse event problem.H11: additional narrative.Zfx received one gentek® angulated screw channel tibase, certain® engaging, 4.1mmd x 1.3mmch with the screw gentek® gold-tite® hexalobular screw, certain®, engaging and one crown for evaluation evaluation.Visual evaluation / functional test was performed.Visual evaluation: gold-tite-screw is in used, but functional condition.Ti-base is separated from crown.Ti base has a crack over the cone.The end of the cone has considerable damages.The crown is broken at the ti-base recording side.It was observed that the crown gets lost on the ti-base and damage the recording from ti-base.Functional test: screw is in dimentions, ti-base fit into implant, dimentional ok.The investigation of this complaint, no lot number was considered since the lot number initially reported was not aligned with the date when the screw was placed.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 did not occur.The screw is in usable condition and within specifications.The reported event is not 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.
Event or Problem Description
No further event information is available at the time of this report.

• 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: 24002987
• Report Number: 0001038806-2026-00110
• Device Sequence Number: 10522610
• 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): 03/24/2026

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
• Date Returned to Manufacturer: 12/12/2025
• 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: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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