BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 CANN PREASSMBL

    MDR report key: 2956167 · Received February 12, 2013

    Report

    Report Number
    2530088-2013-00135
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    December 29, 2012
    Report Date
    January 14, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE VISUAL INSPECTION HAS SHOWN THAT THERE IS A MISALIGNMENT OF THE CONICAL ELEMENTS. SPIRIT AND PANGEA SCREWS MAY SUFFER FROM ABOVE-DESCRIBED DAMAGE WHEN HANDLED IN A CERTAIN MANNER. THIS ISSUE HAS BEEN ADDRESSED AND CORRECTIVE ACTION HAS BEEN TAKEN. THE SPIRIT SURGICAL TECHNIQUE GUIDE HAD BEEN ADAPTED AND AN ADDITIONAL INSERTION GUIDE SLEEVE WAS RELEASED. IT IS NOTED THAT WHEN THE PANGEA SCREWS ARE USED WITH SPIRIT, IT IS VITAL TO AVOID PUSHING FORWARD THE HOLDING SLEEVE WHILE INSERTING AND ADVANCING THE SCREW INTO THE VERTEBRAE. THE SAME APPLIES WHEN ORIENTATING THE HOLDING SLEEVE. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NOT PREVIOUSLY REPORTED. ADDITIONAL CODES: MNI, MNH, KWP, KWO. DEVICE HISTORY RECORDS WERE REVIEWED AND NO NONCONFORMITIES WERE FOUND THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE, THE PANGEA POLYAXIAL SCREW WAS PLACED IN THE HOLDING SLEEVE WITH DIFFICULTY AND WHEN PLACING IT IN THE PATIENT, THE SCREW DISASSEMBLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61789 PEDICSCR PANGEAPOLYAX Ø6 CANN PREASSMBL POLYAXIAL SCREW NKB SYNTHES BRANDYWINE 6740007

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR