BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNEC-ROD Ø6/3.5 L500 Ø6/250 Ø3.5/240 T

    MDR report key: 3231214 · Received July 17, 2013

    Report

    Report Number
    1719045-2013-01793
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWP
    PMA / PMN Number
    K070573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED ON 07/22/2013. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE MANUFACTURING EVALUATION SHOW THAT THE CONNECTING ROD WAS RECEIVED BROKEN IN HALF WHERE IT BEGINS TO NECK DOWN AND BENT IN SEVERAL PLACES. THERE ARE SCRATCHES AND DENTS ALL OVER THE PRODUCT AND THE ANODIZING SEEMS DULL. THE COMPLAINT IS DUE TO AN UNKNOWN CAUSE. THE MATERIAL AND DIAMETER OF THE CONNECTING ROD IS WITHIN SPECIFICATIONS HOWEVER THE MINOR DIAMETER COULD NOT BE MEASURED BECAUSE THAT HALF OF THE ROD IS MISSING. THE LENGTH COULD NOT BE ACCURATELY MEASURED DUE TO THE PRODUCT BEING BROKEN. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PATIENT UNDERWENT A CERVICAL PROCEDURE ON (B)(6) 2013. APPROXIMATELY 3 MONTHS POSTOPERATIVE THE CONNECTING RODS WERE NOTED AS BROKEN. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF THE RODS AND REVISION TO PARALLEL CONNECTORS. THE FOLLOWING DAY THE PATIENT SHOWED HIGH NEUROLOGICAL DEFICIT REQUIRING A NEW PROCEDURE TO IMPLANT A CERVICAL PLATE. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331455 CONNEC-ROD Ø6/3.5 L500 Ø6/250 Ø3.5/240 T KWP SYNTHES MONUMENT 5892735

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR