MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN GOLD-TITE HEXED SCREW; DENTAL SCREW

Catalog Number	IUNIHG
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a loosening on the screw at implant tooth site #46.Unscrewing of the prosthetic screw for the 4th time (each time doctor replaced it with a new screw).This time, doctor remade a new crown with a new tibase abutment.Ti base was placed on (b)(6) 2024 and removed on (b)(6) 2025.Patient suffered from discomfort and pain.This complaint refers to the fourth (and last) loosening event.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D10.Concomitant medical products.Iestb51g - certain 4.1mm (d) x 5.5mm (h) hexed flexlink tm tibase w/ gold-tite screw, lot number 149357.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) iunihg, (certain gold-tite hexed screw) for evaluation.Visual evaluation and a functional test were performed, the screw shows signs of use.Tested the screw with an in-house implant and engages and disengages as intended.Unable to confirm loosening with all the available information.The returned iestb51g and crown have signs of use; however, no damage was identified.It¿s being recorded as a concomitant.Dhr review was completed for the subject lot number 1273497.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 1273497 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: loosening¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was the screw wasn¿t torqued to specification.Therefore, based on the available information, a device malfunction could not be verified.The screw threaded into in-house implant as intended.The reported loosening event was non-verifiable with all the available information.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: CERTAIN GOLD-TITE 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: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23726379
• Report Number: 0001038806-2025-03607
• Device Sequence Number: 16132587
• Product Code: NHA
• UDI-Device Identifier: 00844868008538
• UDI-Public: (01)00844868008538(17)281128(10)1273497
• 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): 01/29/2026

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: IUNIHG
• Device Lot Number: 1273497
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/28/2025
• 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: 12/05/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE.
• Patient Age: 60 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic