BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 6515079 · Received April 24, 2017

    Report

    Report Number
    1030489-2017-00969
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    March 28, 2017
    Report Date
    October 17, 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

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 828-083, 510K# K880215 AND (B)(4) IS APPROVED FOR SALE IN US. (B)(4) (REVISION SURGERY, NON UNION) NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION, HOWEVER PRODUCT IMAGES WERE SUBMITTED AND SUBMITTED IMAGES APPEAR TO DISPLAY FRACTURED RODS, WITH SOME INDICATION OF CYCLIC FATIGUE.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS : VISUAL REVIEW CONFIRMS ROD BREAKAGE. SIGNIFICANT FRACTURE SURFACE SMEARING NOTED. OPTICAL AND MICROSCOPIC EXAMINATION OF THE UNDAMAGED AREAS OF THE FRACTURE SURFACES IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE WITH GENTLY CONVEX PROGRESSIVE STRIATIONS THROUGH THE CROSS-SECTIONAL AREA OF THE ROD, WHICH ARE INDICATIVE OF CYCLIC FATIGUE. DIMENSIONAL INSPECTION ROD DIAMETER CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. NO MATERIAL DAMAGE NOTED ON ADJACENT SURFACE TO CRACK PROPAGATION WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: REMAINING OF ADOLESCENCE IDIOPATHIC SCOLIOSIS IT WAS REPORTED THAT PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE AT LEVELS T5-IL IN WHICH RODS WERE IMPLANTED INTO PATIENT. AT POSTOPERATIVE EXAMINATION, THE RODS WERE FOUND TO BE BROKEN AT THE AREA OF L5/S ON THE BOTH SIDES (WITH CONNECTOR: RIGHT SIDE, WITHOUT CONNECTOR: LEFT SIDE). PATIENT DIDN'T ACHIEVE SOLID FUSION. THE PATIENT UNDERWENT REVISION SURGERY FOR THE REPLACEMENT OF THE RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297604 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0195403W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention