BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALISADE PEDICULAR FIXATION SYSTEM

    MDR report key: 6017492 · Received October 11, 2016

    Report

    Report Number
    2135156-2016-00009
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    NKB
    PMA / PMN Number
    K153323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE BOTH RODS DISENGAGED FROM THE SPINAL CONSTRUCT, SPINEOLOGY IS SUBMITTING TWO (2) MDRS; ONE FOR EACH ROD. THE FOLLOWING MDR NUMBERS REPRESENT THE RODS ASSOCIATED WITH THIS EVENT. REPORT 2135156-2016-00009, 2135156-2016-00010. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PRIOR TO THE INITIAL SURGICAL PROCEDURE, THE PATIENT WAS POSITIONED ON A JACKSON TABLE. THE PATIENT RECEIVED A MULTI-LEVEL SPINAL CONSTRUCT WITH PLACEMENT OF INTERVERTEBRAL BODY FUSION DEVICES ON (B)(6) 2016. DURING PLACEMENT OF THE RODS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RODS FULLY BEYOND THE TULIP HEADS DUE TO INTERFERENCE FROM EITHER SOFT TISSUE OR BONE. MULTIPLE RADIOGRAPHIC IMAGES OF THE FINAL CONSTRUCT WERE TAKEN AT DIFFERENT ANGLES AND THE PHYSICIAN FELT COMFORTABLE WITH THE PURCHASE/INTERFACE OF THE RODS AND SET SCREWS. FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT REPORTED HEARING A "POP" IN HIS BACK WHEN HE WAS ROLLING OVER IN BED. FOLLOW-UP RADIOGRAPHIC IMAGING REVEALED THAT BOTH RODS HAD SLIPPED FROM THE TULIP HEADS AT THE CAUDAL END OF THE CONSTRUCT WHILE THE SET SCREWS REMAINED IN PLACE. THE PHYSICIAN INTENDS TO PERFORM A SECOND SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667797 PALISADE PEDICULAR FIXATION SYSTEM PEDICLE SCREW SYSTEM NKB SPINEOLOGY INC. S16285

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other