BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE HEXED SCREW

    MDR report key: 24441609 · Received February 25, 2026

    Report

    Report Number
    0001038806-2026-00980
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    June 6, 2023
    Report Date
    March 27, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) IUNIHG, (CERTAIN GOLD-TITE TM HEXED SCREW)) 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 1212709. 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 1212709 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H6: ENTERED EVALUATION CODES. H11: ADDED MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D4: LOT/SERIAL # UNKNOWN / NOT PROVIDED. D4: DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. D4: DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. E1: LAST NAME UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SCREW FRACTURED AND WAS REMOVED FROM THE IMPLANT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165664 CERTAIN GOLD-TITE HEXED SCREW DENTAL SCREW NHA ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown