BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 6408519 · Received March 15, 2017

    Report

    Report Number
    1030489-2017-00552
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    February 16, 2017
    Report Date
    April 25, 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. 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.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT 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) (REVISION SURGERY). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. HOWEVER PRODUCT IMAGES WERE SUBMITTED WHICH APPEAR TO DISPLAY BROKEN ROD WITH SOME INDICATION OF CYCLIC FATIGUE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 PEDICLE SUBSTRACTION OSTEOTOMY AT T10-IL. POST-OP, ROD BROKE AT THE AREA NEAR L 5. DUE TO WHICH ON (B)(6) 2017, AN ADDITIONAL SURGERY WAS PERFORMED TO REPLACE THE BROKEN ROD AND FIXATION WAS MADE TO 4-ROD FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188324 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0305381W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention