BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6088588 · Received November 9, 2016

    Report

    Report Number
    1030489-2016-03087
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 12, 2016
    Report Date
    January 18, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL REVIEW CONFIRMED THE IMPLANT IS FRACTURED BETWEEN ~9 THREADS FROM THE BASE OF THE BONE SCREW HEAD. OPTICAL EXAMINATION OF ADJACENT SURFACE AROUND THE POSSIBLE AREA OF CRACK PROPAGATION DID NOT IDENTIFY MATERIAL SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. FRACTURE SURFACE SEVERELY DAMAGED, LIKELY DUE TO REPEATED, CYCLIC IMPACT OF THE UPPER AND LOWER PORTIONS OF THE BONE SCREW, POST-FRACTURE. DIMENSIONAL EXAMINATION OF THE MAJOR AND MINOR DIAMETERS CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. INCONCLUSIVE; THE EXTENT AND SEVERITY OF THE FRACTURE SURFACE DAMAGE RENDERS THE IMPLANT UNSUITABLE FOR FURTHER ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 75446550 AND 510K# K042025 IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION WE CANNOT DETERMINE 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 THE PATIENT UNDERWENT L3-S POSTERIOR SPINAL FUSION(L3-4 TRANSFORAMINAL LUMBAR INTERBODY FUSION, L4-5 POSTERIOR LUMBAR INTERBODY FUSION) POSTOPERATIVE PATIENT HAS ADJACENT SEGMENTAL DISEASE. PATIENT UNDERWENT REVISION SURGERY (TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L1/2). WHEN THE SURGEON REMOVED ROD(S) AND WAS CONFIRMING SCREWS, S1 SCREW WAS FOUND TO BE BROKEN. THE SURGEON COULD REMOVE SOME PART OF THE BROKEN S1 SCREW BUT HE COULD NOT REMOVE SOME PART OF IT AND IT REMAINED IN THE PATIENT AND THE SURGERY WAS FINISHED. THE REVISION SURGERY WAS PLANNED TO INSERT SCREW AT L1/2 AND EXTEND FIXATION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740438 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H11A7141

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention