BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW

    MDR report key: 2151581 · Received June 29, 2011

    Report

    Report Number
    2530088-2011-00162
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK AS TO WHICH 4 OF THE 6 SCREWS WERE REMOVED. THE 4 SCREWS THAT WERE REMOVED WOULD HAVE BEEN EITHER CATALOG #04.632.630, 04.632.635 OR 04.632.740. LOT NUMBER IS UNK. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON IMPLANTED 6 SCREWS, 6 LOCKING CAPS AND 2 RODS ON (B)(6) 2011. TWO DAYS POSTOP, ON (B)(6) 2011, SURGEON DECIDED TO REVISE PT AND REPOSITION ORIGINAL PLACEMENT OF THE SCREWS DUE TO MALPOSITION. DURING REPOSITIONING OF THE HARDWARE, SURGEON EXPERIENCED DIFFICULTY REMOVING 4 OF THE 6 LOCKING CAPS. THE RODS WERE CUT AND 4 SCREWS AND 4 LOCKING CAPS WERE REMOVED WITH VICE GRIPS. SURGEON WAS ABLE TO REMOVE THE OTHER 2 LOCKING CAPS AND 2 SCREWS REMAIN IN THE PT. SURGEON IMPLANTED 4 NEW SCREWS AND 6 NEW LOCKING CAPS. THIS IS THE 4TH OF 4 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI MATRIX POLYAXIAL SCREW MATRIX POLYAXIAL SCREW MNI SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| LOCKING CAPS| RODS