BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/50MM THRD LENGTH

    MDR report key: 2881406 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04222
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    April 19, 2010
    Manufacturer
    SYNTHES
    Product Code
    KWP
    PMA / PMN Number
    K103287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE KWQ, MNH, MNI, NKB. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 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

    EU COMPLAINT HANDLING UNIT REPORTED AN IMPLANT WAS DISPLACED. A PATIENT WITH AN EARLIER LAMINECTOMY, HAD INSTABILITY, ADJACENT LEVELS, AND HAD TO BE REOPERATED ON. HE WAS FIXED WITH A PANGEA. EVERYTHING WENT WELL UNTIL HE TRIED TO LIFT A HEAVY OBJECT 18 MONTHS LATER. HE SUFFERED FROM EXCRUCIATING PAIN, RADIATING DOWN HIS RIGHT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/50MM THRD LENGTH 6.0MM TI PANGEA(TM) POLYAXIAL KWP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention