BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 7163232 · Received January 4, 2018

    Report

    Report Number
    1030489-2018-00010
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    January 1, 2017
    Report Date
    May 9, 2018
    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 PRODUCT WITH CATALOG# 828-083, 510K# K880215 AND (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: AN ~3.5CM PORTION OF THE ROD WAS RETURNED. VISUAL AND MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE WITH GENTLY CONVEX PROGRESSIVE STRIATIONS THROUGH THE CROSS-SECTIONAL AREA OF THE ROD, WHICH IS INDICATIVE OF CYCLIC FATIGUE. NO MATERIAL DAMAGE NOTED ON THE ADJACENT SURFACE TO THE CRACK PROPAGATION WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FIXATION ON T10-ILIAC DUE TO LUMBAR KYPHOSCOLIOSIS. REPORTEDLY, POST-OP, ROD BROKE ON THE LEFT SIDE OF L4/5. THE PATIENT UNDERWENT REVISION FOR REMOVAL OF THE ROD. NO FRAGMENTS REMAINED INSIDE THE PATIENT'S BODY AFTER REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7355 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention