BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL ABUTMENT SCREW

    MDR report key: 15685578 · Received October 27, 2022

    Report

    Report Number
    0002023141-2022-02708
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    February 10, 2022
    Report Date
    November 7, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B3: DATE OF THE EVENT WAS UPDATED. B4: DATE OF THIS REPORT WAS UPDATED. B5: EVENT DESCRIPTION WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H10: NARRATIVE/DATA WAS UPDATED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: TSVTWB11, IMP,TSV,4.7,11.5,MTX,MG, LOT NUMBER 1222920. PMA/510(K) NUMBER NOT AVAILABLE. NO DEVICE CATALOG OR LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. SINCE THE DEVICE WILL NOT BE RETURNED, IDENTIFYING A DEFINITIVE ROOT CAUSE WILL NOT BE POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH IDENTIFIES THE PRODUCT OR INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON FOLLOW UP, THE CUSTOMER CONFIRMED THE EVENT DATE (B3).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CROWN CAME LOOSE, AND THE ABUTMENT/SCREW WAS RE-TORQUED. TOOTH LOCATION #30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599777 DENTAL ABUTMENT SCREW NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female DENTAL IMPLANT.