MAUDE Adverse Event Report: ZIMVIE US CORP LLC ABUT HEX-LOCK 3.5MM IMP 4 .5 FLARE; DENTAL ABUTMENT

Catalog Number	HLA3/4
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the prosthesis was placed and tightened permanently with 30 ncm at tooth site #12.After a month, the crown was moving.Unfortunately, it wasn't the crown that was moving, but the abutment.The patient returned several times with the same problem but the issue couldn't be solved.In (b)(6), dentist replaced it because it seemed like the friction fit connection was not fitting correctly.Patient referred pain.Abutment was placed on (b)(6) 2025 and removed on (b)(6) 2026.This event is created to represent the first loosening.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D9: device availability unknown / not provided.G4: premarket identification k013227.
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.Zimvie did not receive one (1) hla3/4, (abut hex-lock 3.5mm imp 4.5 flare) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 2120029289.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 2120029289 for similar events and two other complaints were 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 abutment screw is not torqued to specification.Therefore, based on the available information, a device malfunction could not be verified.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: ABUT HEX-LOCK 3.5MM IMP 4 .5 FLARE
• Common Device Name: DENTAL ABUTMENT
• 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: 24330892
• Report Number: 0001038806-2026-00720
• Device Sequence Number: 20088276
• Product Code: DZE
• UDI-Device Identifier: 00889024015166
• UDI-Public: (01)00889024015166(17)300311(10)2120029289
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K011028
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: HLA3/4
• Device Lot Number: 2120029289
• 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: 02/13/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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 Age: 39 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic