BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 CORTICAL BONE SCREW 18MM

    MDR report key: 7798947 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08339
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    July 19, 2018
    Report Date
    June 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PK905048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT- PLATE 100 DEG TUBULAR 5 HOLE CATALOG#: 143555 LOT#: 450850, 4.0 MM SOLID CANC SCR 30 MM CATALOG#: 1436930 LOT#: SC3937, 4.0 MM SOLID CANC SCR 30 MM CATALOG#: 1436930 LOT#: J-DMJ CD3, 3.5 CORT BONE SCREW 18 MM CATALOG#: 1437718 LOT#: J3798154. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08323, 0001825034-2018-08331 0001825034-2018-08336, 0001825034-2018-08338.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED ECZEMA CAUSED BY AN ALLERGIC REACTION FOLLOWING IMPLANTATION OF THE TRAUMA PLATE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638311 3.5 CORTICAL BONE SCREW 18MM PLATE, FIXATION HWC ZIMMER BIOMET, INC. N/A J3798154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention