BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROLIFT VBR SZ.6 (57-93.5MM)/ENDPL.L

    MDR report key: 4359487 · Received December 3, 2014

    Report

    Report Number
    3005673311-2014-00091
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    MQP
    PMA / PMN Number
    K083186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: VISUAL INSPECTION: THE HYDROLIFT ARRIVED DECONTAMINATED WITHOUT ORIGINAL BOX. THE IMPLANT EXHIBITS NO DAMAGES. DISTRACTION TEST: TESTED THE IMPLANT WITH AN MERIT BLUE DIAMOND INFLATION DEVICE. RESULT: UP TO 30 BAR, THE HYDROLIFT SHOWS NO LEAKAGE. NO ABNORMALITY (SUCH AS STICKING) WAS NOTED. CONCLUSION: THE DESCRIBED ERROR COULD NOT BE DETECTED, THE IMPLANT WORKS WITHOUT ANY ABNORMALITY, NO FAILURE COULD BE FOUND.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING CORPORECTOMY LWK 2 AND 3 THE SURGEON TRIED TO DISTRACT THE HYDROLIFT SV018T WITH AN FW450SU / HYDROLIFT HYDRAULIC APPLICATOR. AT 26 BAR, PRESSURE THE CONNECTION TUBE BURST. SURGEON OBTAINED A SECOND FW450SU, THE CONNECTION BURSTS AGAIN, AT 25 BAR. IMPLANT WAS REMOVED AND TESTED WITH A THIRD FW450SU OUTSIDE THE BODY. ON THE FIRST 10MM THEY NOTICED A SLIP STICK EFFECT, THEN THE HYDROLIFT DISTRACTED WITHOUT PROBLEMS. TESTED OUTSIDE UNTIL 20 BAR. SURGEON IMPLANTED THE HYDROLIFT AGAIN AND TRIED THE DISTRACTION AGAIN. LUERLOCK CONNECTOR BURSTS AT 24 BAR. SOME OF THE NACL SOLUTION SPRAYED UP ON THE UNSTERILE LUMINAIRE AND DRIPPED INTO THE PT. THE TRIAL TO DISTRACT THE HYDROLIFT MANUALLY MISCARRIED. SURGEON EXPLANTED THE HYDROLIFT AND USED AN ULLRICH OBELISK SUCCESSFULLY. THE PT WAS GIVEN 7 DAYS OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782530 HYDROLIFT VBR SZ.6 (57-93.5MM)/ENDPL.L VERTEBRAL BODY REPLACEMENT MQP AESCULAP AG AND CO. KG SV018T 51746211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other