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

Catalog Number	ILRGHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A2: age at time of the event: unknown / not provided.A3: gender: unknown / not provided.A4: patient weight: unknown / not provided.B3: date of event: unknown / not provided.D10.Concomitant medical products: ilrght, certain® titanium large hexed screw lot 1281721.E1: reporter name: unknown / not provided.G4: premarket identification: k072642.
Event or Problem Description
The doctor reported that the 2 screws fractured by the body.Procedure completed.
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) ilrght, (certain titanium large hexed screw) for evaluation.Visual evaluation was performed, slight wear however no fracture/malfunction identified.Dhr review was completed for the subject lot number 1285962.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 1285962 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: dental: functional: fracture: screw.A definitive root cause could not be determined since the device malfunction did not occur, and the reported event has been unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.No fracture/malfunction identified.The reported event is unconfirmed.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 LARGE 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: 24244252
• Report Number: 0001038806-2026-00518
• Device Sequence Number: 18219986
• Product Code: DZE
• UDI-Device Identifier: 00844868006138
• UDI-Public: (01)00844868006138(17)290806(10)1285962
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K972444
• 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): 03/13/2026

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: ILRGHT
• Device Lot Number: 1285962
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/12/2026
• 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: 02/03/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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 SCREW SEE H10 NARRATIVE.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic