BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø5.5 PREAS

    MDR report key: 3003568 · Received March 14, 2013

    Report

    Report Number
    2530088-2013-00308
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 17, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: MNH, MNI, KWQ, KWP. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ALL MED WATCHES FOR 2530088-2013-00308, INITIAL AND FOLLOW, UP ARE BEING RETRACTED FOR THIS PART AS THIS IS A DUPLICATE COMPLAINT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: LOCKING CAP BLOCKED. ON (B)(6) 2013, POST-OPERATIVELY, THE DOCTOR CHECKED AN X-RAY IMAGE AND FOUND THE L4 SCREWS WERE OUT SIDE OF THE PEDICLE. SUBSEQUENTLY, THE DOCTOR PERFORMED A REINSERTION OF THE SCREWS. HE COULD NOT REMOVE THE CAP, BECAUSE A BLOCKING PHENOMENON WAS FOUND BETWEEN THE CAP AND THE ROD. THE COUNTER TORQUE, RATCHET-HANDLE10NM AND DRIVER WITH HIGH DEGREE OF HARDNESS WERE USED. NEXT THE DOCTOR USED A PERSUADER TO ACCELERATE THE PEELING OFF OF A LITTLE ANCHORING BUT WAS UNSUCCESSFUL. THE DOCTOR CHECKED WITH TSUDA-SAN REGARDING THE USE OF THE THREADED PERSUADER AND TRIED TO USE IT. HOWEVER, HE COULD NOT FIND THE HEX SOCKET SO HE COULD NOT USE IT. WHILE HE WAS LOOKING FOR ANOTHER APPROACH, THE SHAFT BROKE INSIDE OF THE CAP. THE DOCTOR REMOVED IT TOGETHER WITH THE SCREW AFTER HE CUT THE ROD BY USE OF JUMBO CUTTER. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107567 PEDICSCR MATRIX 5.5 POLYAXIAL Ø5.5 PREAS NKB SYNTHES BRANDYWINE 6430446

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention