MAUDE Adverse Event Report: ZimVie US Corp LLC CERTAIN® TITANIUM HEXED SCREW; Dental Screw

Catalog Number	IUNIHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient presented with the crown and fractured screws.The screws had fractured at the head, with the fractured head remaining inside the crown, while the remaining portion of the screws had not only become detached but had also unscrewed and was found in the patient¿s mouth.Tooth site 36.Placed on (b)(6)2026 and removed on (b)(6)2026.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10.Concomitant medical products: iuniht, certain® titanium hexed screw lot 1022813.

• 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 ; +1(561)971-3230
• MDR Report Key: 50930159
• Report Number: 0001038806-2026-04932
• Device Sequence Number: 15829799
• Product Code: NHA
• UDI-Device Identifier: 00844868008545
• 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
• Report Date (Section B): 09/29/2026

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: Lay User/Patient
• Device Catalogue Number: IUNIHT
• Device Lot Number: 1304626
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Dental screw See H10 Narrative
• Patient Age: 72 YR
• Patient Sex: Male