BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 24799123 · Received April 7, 2026

    Report

    Report Number
    0001038806-2026-01829
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: CATALOG # UNKNOWN / NOT PROVIDED. D4: LOT/SERIAL # UNKNOWN / NOT PROVIDED. D4: DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. D4: DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) UNKNOWN BIOMET SCREW FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, AND RISK MANAGEMENT FILE (RMF). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR, STERILIZATION, AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE SUBJECT LOT NUMBER ASSOCIATED WITH THE UNKNOWN BIOMET 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 IS PARAFUNCTIONAL HABITS/PATIENT FACTORS. 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 PRODUCT WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # UNKNOWN HAS A FRACTURED SCREW. SCREW BROKE INSIDE OF IMPLANT. THE IMPLANT HAS NOT BEEN REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60561 DENTAL SCREW DZE ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1