BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC SELF-LOCKING CERVICAL SCREW 4.0X18MM

    MDR report key: 6421885 · Received March 21, 2017

    Report

    Report Number
    9610612-2017-00121
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Report Date
    October 16, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    KWQ
    PMA / PMN Number
    K050813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT A REVISION PO HAD TO BE PERFORMED DUE TO ABSCESS WITH ABC 2 SCREW COMPONENT. CONCOMITANT MEDICAL PRODUCTS: FJ934T / ABC SELF-LOCKING CERVICAL SCREW 4.0X18MM; FJ750T / ABC CERVICAL PLATE 4 HOLE TA 24MM.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: KEYENCE VHX 600 D DIGITAL MICROSCOPE. PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE DEFECTIVE SCREWS AND THE PLATE. AT THE SCREWS AND TWO HOLES IN THE PLATE, WE FOUND WEAR MARKS, CAUSED BY RELATIVE MOVEMENTS BETWEEN SCREW HEAD AND PLATE. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE FOR THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES WE ASSUME THAT THE SCREWS WERE NOT APPLIED/TIGHTENED PROPERLY. THE WEAR MARKS ON BOTH DEFECTIVE SCREWS ARE CLEAR HINTS FOR RELATIVE MOVEMENT BETWEEN SCREW AND PLATE. THIS CAN GO SO FAR THAT THE EDGE OF THE SLOT HOLE OF THE PLATE CAN ABRADE PETALS. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203510 ABC SELF-LOCKING CERVICAL SCREW 4.0X18MM ABC SYSTEM IMPLANTS KWQ AESCULAP IMPLANT SYSTEMS FJ934T 52042800

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other FJ750T / ABC CERVICAL PLATE 4 HOLE TA 24MM| FJ934T / ABC SELF-LOCKING CERVICAL SCREW 4.0X18MM| FJ750T / ABC CERVICAL PLATE 4 HOLE TA 24MM| FJ934T / ABC SELF-LOCKING CERVICAL SCREW 4.0X18MM