BEUDAMED
    FDA Adverse Event Summary report: N

    TSPACE PEEK IMPLANT 5 DEGREES 26X11.5X7MM

    MDR report key: 3202357 · Received June 21, 2013

    Report

    Report Number
    3005673311-2013-00062
    Date Received
    June 21, 2013
    Report Date
    June 6, 2013
    Manufacturer
    AESCULAP QG AND CO. KG
    Product Code
    MAX
    PMA / PMN Number
    K071983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: SJ907P LOT 51898458 WAS CORRECTLY MOUNTED ON THE INSERT INSTRUMENTS. THE IMPLANT HAS FRACTURED IN THE HORIZONTAL PLANE THROUGH THE SCREW THREAD CONNECTING IT TO THE INSTRUMENT ON THE POSTERIOR (INNER CURVED) SIDE. THE CRACKING SUGGESTS THAT THE IMPLANT UNDERWENT HIGH INSERTION FORCES, INDICATING THAT THE DISC SPACE WAS NOT SUFFICIENTLY PREPARED/DISTRACTED. THE CAGE HAS FRACTURED DUE TO USER RELATED HANDLING ERRORS. THE MANUFACTURING DOCUMENTATION HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS FOR A MATERIAL OR MANUFACTURING DEFECT. NO DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH OCCURRED. THE EVENT IS BASED ON AN ACT/OMISSION OF ACT, THAT HAS A DIFFERENT RESULT TO THAT INTENDED. AESCULAP (B)(4) DETERMINED THAT A FIELD SAFETY NOTIFICATION WOULD BE RELEASED AND THAT ADDITIONAL HANDLING AND LOADING CAUTIONARY STATEMENTS WOULD BE ADDED TO THE (B)(6) INSTRUCTIONS FOR USE (IFU). THIS ACTION/DECISION WAS REVIEWED IN THE US. SAID REVIEW DETERMINED REMEDIAL ACTION IS NOT REQUIRED IN THE US AS THE US VERSION OF THE IFU ALREADY HAS SIMILAR CAUTIONARY STATEMENTS. IT SHOULD BE NOTED THAT, CURRENTLY, WE DO NOT HAVE SIMILAR COMPLAINTS INITIATED IN THE US.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). IMPLANT BROKEN. WHILE INTRODUCING THE IMPLANT A FRACTURE OF IT OCCURRED. WE HAVE NO INFORMATION, THAT THE SURGERY COULD NOT BE FINISHED NOR OF NEGATIVE OUTCOME FOR PATIENT. WE ASSUME THAT THE SURGICAL DELAY WAS MORE THAN 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284203 TSPACE PEEK IMPLANT 5 DEGREES 26X11.5X7MM MAX AESCULAP QG AND CO. KG SJ907P 51898458

    Patients

    Seq Age Sex Outcome Treatment
    1