BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI CANN MATRIX POLYAXIALSCREW 45MM THREAD

    MDR report key: 2211417 · Received August 9, 2011

    Report

    Report Number
    2530088-2011-00507
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 11, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH RODS, PANGEA SCREWS AND LOCKING CAPS FOR AN L4-L5 ON (B)(6) 2011. DURING A FOLLOW UP VISIT, IT WAS NOTED ON X-RAY THAT THE RIGHT L4 LOCKING CAP WAS LOOSE. DURING REVISION SURGERY ON (B)(6) 2011, IT WAS DISCOVERED THAT THE REASON THE LOCKING CAP WAS LOOSE WAS BECAUSE THE COLLET WAS TURNED INSIDE THE HEAD OF THE POLYAXIAL SCREW. THIS DID NOT ALLOW THE ROD TO SEAT ALL THE WAY AND THE LOCKING CAP COULD NOT BE FINAL TIGHTENED. THIS OCCURRED DURING THE ORIGINAL PROCEDURE BUT WAS NOT DISCOVERED UNTIL REVISION SURGERY. SURGEON REMOVED AND REPLACED THE RIGHT L4 AND L5 LOCKING CAP, RIGHT L4 SCREW. THE RIGHT L5 SCREW REMAINED INTACT AND THE ROD WAS RE-IMPLANTED. THE RIGHT L4 SCREW IS AVAILABLE FOR RETURN, THE LOCKING CAPS WILL NOT BE RETURNED. THIS IS THE 1ST OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI CANN MATRIX POLYAXIALSCREW 45MM THREAD MATRIX POLYAXIAL SCREW NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention LOCKING CAPS| RODS| SCREWS