MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® TITANIUM HEXED SCREW; DENTAL SCREW

Catalog Number	IUNIHT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: concomitant medical product: ilrght, certain® titanium large hexed screw, lot: 1299289.
Event or Problem Description
It was reported that the screws were loosened and did not hold the crowns properly, and the screws were removed.No other screws were used in exchange.
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 received one (1) iuniht, (certain titanium hexed screw) for evaluation.Visual evaluation and a functional test were performed, the screw shows signs use.The screw threaded into in-house abutment and implant as intended.Measurements match drawing and engaged thread ring.Unable to confirm loosening with all the available information.Dhr review was completed for the subject lot number 1258670.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 1258670 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 abutment screw was not 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® TITANIUM 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: 24578130
• Report Number: 0001038806-2026-01330
• Device Sequence Number: 9435453
• Product Code: NHA
• UDI-Device Identifier: 00844868008545
• UDI-Public: (01)00844868008545(17)270929(10)1258670
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/11/2026

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: IUNIHT
• Device Lot Number: 1258670
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/26/2026
• 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: 03/12/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL SCREW SEE H10 NARRATIVE.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic