BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVIC-DISTRACT R W/ADJUST-ANGLE

    MDR report key: 3221040 · Received July 11, 2013

    Report

    Report Number
    8030965-2013-04282
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HST
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION OF THE COMPLAINED CERVICAL DISTRACTOR CONFIRMED THAT ONE ARM IS BROKEN OFF AT THE JOINT FOR THE VARIABLE ANGLE. THE LCP DRILL BIT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD RESEARCHED AND NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. THE CAUSE IS UNKNOWN. THIS IS INDICATIVE OF TOO MUCH MECHANICAL FORCE APPLIED DURING THE SURGERY. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE INSTRUMENT BROKE IN THE BEGINNING OF AN ANTERIOR CERVICAL DECOMPRESSION AND FUSION (ACDF) SURGERY ON (B)(6) 2013 (CERVIOS CAGE). THERE WAS NO HARM FOR THE PATIENT OR THE OPERATOR. THE INCIDENT DELAYED THE OPERATION FOR ABOUT 5 MINUTES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319505 CERVIC-DISTRACT R W/ADJUST-ANGLE HST SYNTHES GMBH T953280

    Patients

    Seq Age Sex Outcome Treatment
    1