BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1823559 · Received August 27, 2010

    Report

    Report Number
    1030489-2010-01107
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    HSB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PART# AND LOT# OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE RODS THAT WERE USED ARE CATALOG # GX0299H031, LOT # W07E2256; CATALOG # GX8699045, LOT # W07A608. NON-FUSION. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8699055, 510K # K981676 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURER DATE FOR LOT # W07E2256 IS 05/11/2007; THE MANUFACTURER DATE FOR LOT # W07A4608 IS 02/22/2007. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT L4-S1. THE FIXATION SCREWS WERE NOT IMPLANTED TO L5. THE PT REPORTEDLY DID NOT FUSE THREE YEARS AFTER. THE LEFT SIDE ROD WAS BROKEN. THE ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE CONSTRUCT. THE FIXATION LEVEL WAS EXTENDED FROM L4 TO S2 BY A PLF. THERE WAS STILL NO SCREW IMPLANTED AT L5. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM ROD HSB WARSAW ORTHOPEDIC INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention EXPLANTED:| IMPLANTED:| SET SCREWS:| PEDICLE SCREWS:| IMPLANTED:| IMPLANTED:| EXPLANTED:| ROD:| EXPLANTED: