BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 6583762 · Received May 23, 2017

    Report

    Report Number
    1030489-2017-01289
    Event Type
    Injury
    Date Received
    May 23, 2017
    Report Date
    July 13, 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

    PRODUCT ANALYSIS:VISUAL REVIEW CONFIRMS ROD BROKEN. MULTIPLE WITNESS MARKS NOTED ON ROD. OPTICAL EXAMINATION DID NOT IDENTIFY SURFACE DEFECT IDENTIFIED IMMEDIATELY ADJACENT TO THE AREA OF INITIAL CRACK PROPAGATION THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION. 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.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN U.S. BUT A SIMILAR DEVICE WITH CATALOG# 828-090, 510K# K964275 AND UDI (B)(4) IS APPROVED FOR SALE IN U.S. (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

    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 KYPHOSIS UNDERWENT VERTEBRAL COLUMN RESECTION (VCR) AT T10-IL.ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE; HOWEVER THE PATIENT HAD ACHIEVED SOLID FUSION. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE BROKEN ROD. THERE WERE NO FRAGMENTS OF IMPLANT REMAINING IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365377 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention