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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) a2: age and date of birth unknown / not provided a3: gender unknown / not provided a4: patient weight unknown / not provided b3: date of event unknown / not provided e1: phone number unknown / not provided h11: d10 - medical product - certain bellatek titanium abutment 4.1mm catalog #: ildat4 lot #:unknown / not provided.
Event or Problem Description
It was reported that the gold screw was not able to seat all the way.The screw was loose and thus the whole crown/abutment had movement.We were able to retrieve the gold screw, but the abutment was lodged into the implant and would not come out.The abutment and crown had to be cut to be removed.Tooth #13.The implant is ok and i still have the remaining crown and abutment.

• 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: 25216153
• Report Number: 0001038806-2026-02758
• Device Sequence Number: 13262207
• Product Code: NHA
• UDI-Device Identifier: 00844868008538
• UDI-Public: (01)00844868008538(17)300126(10)1294753
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: IUNIHG
• Device Lot Number: 1294753
• 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
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: D10, MEDICAL PRODUCT: SEE H11 NARRATIVE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic