BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 23590009 · Received November 18, 2025

    Report

    Report Number
    0001038806-2025-03272
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 22, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) UNKNOWN ZIMMER 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, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE [UNKNOWN ZIMMER SCREW] IS NOT AVAILABLE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT AND ENSURE THE PRODUCT IS WITHIN SPECIFICATIONS. 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 TORQUE APPLIED DURING PLACEMENT/ SEATING EXCEEDS RECOMMENDED VALUE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. 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. H10: ADDED MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    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 THAT IMPLANT HAD FRACTURED SCREW. IMPLANT IS INPATIENT'S MOUTH WITHOUT ANY ISSUES. ADDITIONAL APPOINTMENT REQUIRED FOR SCREW REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275089 DENTAL SCREW DZE ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown