BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAMETER 4X16MM

    MDR report key: 7078895 · Received December 4, 2017

    Report

    Report Number
    3005180920-2017-00722
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 4, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630030841347
    PMA / PMN Number
    K140361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 24 NOVEMBER 2017. SIX MONTHS AFTER PRIMARY SURGERY, A SCREW OF A CERVICAL PLATE BROKE IN THE VERTEBRAL BODY. THE CAUSE FOR FRACTURE IS PROBABLY DELAYED FUSION; ALL THESE IMPLANTS ARE MEANT TO CARRY LOAD ONLY TEMPORARILY. AS THE IMPLANT HAS NOT BEEN RETRIEVED, WE COULD NOT ANALYZE IT IN ORDER TO VERIFY IF A MANUFACTURING DEFECT IS PRESENT. THE POSSIBILITY OF FUSION FOR THE PATIENT IS PROBABLY HINDERED BUT NOT DEFINITELY COMPROMISED; AT 9 MONTHS, IT SEEMS IMPROVED BUT CLINICAL ANALYSIS IS NOT AVAILABLE. BATCH REVIEW PERFORMED ON 01 DECEMBER 2017: LOT 141344: 104 ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2014. EXPIRATION DATE: 30- SEPT- 2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    MEDACTA INTERNATIONAL WAS INFORMED ON (B)(6) 2017 ABOUT A SCREW BREAKAGE OCCURRED FEW MONTHS BEFORE. THE EVENT WAS NOTICED DURING A POST-OPERATIVE CONTROL. TO DATE, WE DO NOT KNOW IF THE REVISION SURGERY HAS BEEN PERFORMED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858203 CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAMETER 4X16MM CERVICAL SCREW KWQ MEDACTA INTERNATIONAL SA 141344 07630030841347

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention