BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6172782 · Received December 13, 2016

    Report

    Report Number
    1030489-2016-03410
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 18, 2016
    Report Date
    March 3, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840016540, 510K # K091974, (B)(4) WAS CLEARED IN THE UNITED STATES. IMAGE REVIEW: SUBMITTED IMAGES APPEARED TO DISPLAY THREAD FLANK AND CREST SKIVING, DEFORMATION AND DAMAGE. PRODUCT ANALYSIS : VISUAL EXAMINATION OF THE MAS HEAD IDENTIFIED A PORTION OF THE FIRST THREAD ON ONE SIDE IS BROKEN OFF. THE BROKEN-OFF PORTION OF THE HEAD IS MISSING AND NOT RETURNED FOR ANALYSIS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS HEAD AND SET SCREW DURING CONSTRUCT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840016540, 510K # K091974 WAS CLEARED IN THE UNITED STATES. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH LUMBAR DEGENERATIVE SPONDYLOLISTHESIS UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (INTERMUSCULAR APPROACH) AT L4/5. INTRA-OP, THERE WAS CROSS-THREAD ON THE SCREW AT L5 AND THE SURGEON REINSERTED SET SCREW TO THE SCREW SEVERAL TIMES BUT THE SURGEON COULD NOT PERFORM FINAL TIGHTENING. SURGEON CONSIDERED THAT POSSIBILITY OF BROKEN THREAD OF SCREW OR WIDENING OF HEAD. SURGEON REMOVED THE RELEVANT SCREW AND INSERTED ONE SIZE BIGGER SCREW (F7.5). CORRECTION AT L4 FOR SPONDYLOLISTHESIS HAD ALREADY BEEN CONDUCTED USING REDUCTION SCREWS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820504 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H5148812

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR