BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISSYS LP SPINAL SCREW

    MDR report key: 1765522 · Received July 2, 2010

    Report

    Report Number
    3005129649-2010-00002
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 1, 2010
    Manufacturer
    CUSTOM SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K072866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG NUMBER: 046555. THE PRODUCT LOT NUMBERS WERE NOT PROVIDED. THE REPRESENTATIVE STATED THERE WAS LACK OF FUSION OF THE AFFECTED AREA. THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. AT THIS TIME THERE IS INSUFFICIENT EVIDENCE TO DRAW A CONCLUSION FOR THE ALLEGED SCREW BREAKAGE, ALTHOUGH POTENTIAL PSEUDOARTHROSIS APPEARS TO BE A POTENTIAL CAUSE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WENT TO THE DOCTOR EXPRESSING LOWER BACK PAIN. THE PATIENT HAD A PRIOR SURGERY AT THE L2-L5 LEVELS ON (B)(6) 2007. THE DOCTOR PERFORMED CT SCAN AND THE POST OPERATIVE DIAGNOSIS WAS PATIENT HAD PSEUDOARTHROSIS AT L4-L5. THIS SECTION WAS PREVIOUSLY TREATED IN THE INITIAL SURGERY ((B)(6) 2007). THE DOCTOR IDENTIFIED BROKEN SCREWS AT L5. THE SCREWS WERE IDENTIFIED AS CAT # 046550, LOT INFORMATION NOT PROVIDED (6.5 MM DIAMETER X 50 MM LENGTH) AND CAT# 046555, LOT INFORMATION WAS NOT PROVIDED (6.5 MM DIAMETER X 55 MM LENGTH). A REPEAT SURGERY WAS PERFORMED TO REMOVE BROKEN SCREWS FROM THE AFFECTED VERTEBRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISSYS LP SPINAL SCREW PEDICLE SCREW SPINAL SYSTEM NKB CUSTOM SPINE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention