BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 21080376 · Received January 6, 2025

    Report

    Report Number
    0002023141-2025-00030
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    October 12, 2024
    Report Date
    April 30, 2025
    Manufacturer
    ZIMMER DENTAL
    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 COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED D1: BRAND NAME UNKNOWN / NOT PROVIDED D4: LOT/SERIAL # UNKNOWN / NOT PROVIDED D4: DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED D4: DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED G4: ADDITIONAL PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) UNK 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 [UNK 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 SUBMITTED IMAGES FOR THE REPORTED EVENT. X-RAY IMAGE SHOWS THE IMPLANT FRACTURED CAPTURED IN CE-77771-2024. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00556-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS ABUTMENT SCREW IS NOT TORQUED TO SPECIFICATION. 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", H3: CHANGED "YES" TO "NO", H6: ENTERED EVALUATION CODES, H10: ADDED MANUFACTURER NARRATIVE, H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PRESENTED WITH A LOOSE SCREW, IT WAS REPLACED WITH A NEW SCREW.

    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
    1137835 DENTAL SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male