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 Codes	Inflammation (1932); Pain (1994)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D4: expiration date: unknown / not provided.E1: phone #: (b)(6).
Event or Problem Description
It was reported that the screw loosened and was removed.Tooth location 14, ti base placed on (b)(6) 2024 and removed on (b)(6) 2026.The prosthetic component was slightly mobile.Gingival inflammation and pain were reported as a result of the event.Procedure was completed with another screw.
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 h11: additional narrative zfx received one screw gentek® gold-tite® hexalobular screw, certain®, engaging for evaluation.Visual evaluation / functional test was performed.Visual evaluation: gold-tite-screw is in used, but functional condition.Functional test: scerw is in tolerances.Complaint history review was performed for the reported lot number 0000230428 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿loosening¿.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 conforming to all required specifications.The reported event is un-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: 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: 24266380
• Report Number: 0001038806-2026-00575
• Device Sequence Number: 10722878
• Product Code: NHA
• UDI-Device Identifier: 04251881714364
• UDI-Public: (01)04251881714364(10)0000230428(240)ZFX11ZB-CE41AS13E
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/23/2026

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: 0000230428
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/16/2026
• 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: 02/05/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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: 47 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic