BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2012-04292

    MDR report key: 2884056 · Received December 21, 2012

    Report

    Report Number
    2520274-2012-04292
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    July 2, 2010
    Report Date
    August 23, 2010
    Manufacturer
    SYNTHES
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE EXACT PART NUMBER COULD NOT BE IDENTIFIED. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE WAS NOT RETURNED TO MANUFACTURING. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A REVISION DUE TO RODS DISENGAGING. THE REVISION WAS ON A PANGEA, DIAMETER 6 MM RODS, DISENGAGING BILATERALLY POST-OPERATION. THERE WAS NO RECOGNIZABLE SLIPPAGE. THE SURGEON HAD USED THE PRODUCT FOR A FEW YEARS AND IS VERY EXPERIENCED. UNABLE TO EXPLAIN THE REASON FOR THE ROD DISENGAGEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KWP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention