BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH

    MDR report key: 6566093 · Received May 14, 2017

    Report

    Report Number
    1030489-2017-01216
    Event Type
    Malfunction
    Date Received
    May 14, 2017
    Date of Event
    April 18, 2017
    Report Date
    June 20, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    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

    ADD'L INFO.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOR APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 828-090, 510K# K964275 AND UDI# (B)(4) IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL REVIEW CONFIRMS ROD BROKEN. MULTIPLE WITNESS MARKS NOTED ON ROD. NO SURFACE DEFECT IDENTIFIED IMMEDIATELY ADJACENT TO THE AREA OF INITIAL CRACK PROPAGATION THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION. SIGNIFICANT FRACTURE SURFACE DAMAGE AND SMEARING IS NOTED. MICROSCOPIC EXAMINATION OF THE UNDAMAGED PORTIONS OF THE FRACTURE SURFACE IDENTIFIED A FAIRLY FLAT FRACTURE, WITH INITIAL GENTLY CONVEX PROGRESSIVE STRIATIONS AND BEACH MARKS THROUGH THE CROSS-SECTIONAL AREA. DIMENSIONAL INSPECTION CONFIRMS ROD DIAMETER TO BE WITHIN PRINT SPECIFICATION. AFTER VISUAL, MICROSCOPIC AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANTS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE AS THE MECHANISM OF FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT REVISION SURGERY WHEREIN THE ROD WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT VERTEBRAL COLUMN RESECTION DUE TO SCOLIOSIS IN WHICH ROD WAS IMPLANTED AT LEVELS TH5/IL.POST-OP, X-RAY IMAGES REVEALED THE BREAKAGE OF ROD AROUND LEFT L4/5.REVISION SURGERY WAS PLANNED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347285 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0443632W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention