BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11830852 · Received May 17, 2021

    Report

    Report Number
    2647346-2021-00023
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING PRODUCTS WERE USED IN THE PROCEDURE. PRODUCT ID: G75446545; LOT#H5427621, QUANTITY: 4 .PRODUCT ID: G75447545; LOT#H5481706, QUANTITY: 2. THIS DEVICE IS NOT MARKETED IN US. HOWEVER, A SIMILAR DEVICE (SCREW X0808228 6.0 X 55 TI REDUCTION MAS), IS SOLD IN THE US WITH UDI #(B)(4) AND 510(K) NO. K042025. 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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT UNDERGOING A REVISION SURGERY FOR A SPINAL THERAPY. IT WAS REPORTED THAT, ON (B)(6) 2019, PLF OF L2-3-4-5, FIXATION WITH LEGACY. ON (B)(6) 2021, POSTERIOR FIXATION AT T10-IL WAS PERFORMED FOR THE OCCURRENCE OF LOWER LIMB SYMPTOM DUE TO THE LOOSENING ON THE LEFT AND RIGHT OF L2 AND FRACTURE OF THE PEDICLE ON THE RIGHT OF L5, AND PLIF WAS PERFORMED AT L5-S1. THERE WAS HEALTH DAMAGE TO THE PATIENT. THERE WAS NO SPECIFIC PRODUCT MALFUNCTION. THE PRODUCTS WILL BE RETURNED TO THE PATIENT. DEVICE STATUS REASON : EXPLANTED-COMPLETE THE 4 SCREWS (G75446545) WERE USED AT THE POSITION OF LOOSENESS ON THE LEFT AND RIGHT OF L2 AND THE OTHER TWO (G75447545) WERE USED AT THE POSITION OF FRACTURE ON THE RIGHT SIDE OF L5. THE LOWER LIMB SYMPTOM WAS NEUROLOGICAL SYMPTOM ASSOCIATED WITH FRACTURE OF THE RIGHT PEDICLE OF L5. THE PAIN CAUSED THE PATIENT TO UNDERGO THE REOPERATION. THE SCREWS DID NOT CAUSE/CONTRIBUTE TO THE PEDICLE FRACTURE AT L5. THE CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728911 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT PUERTO RICO OPERATIONS CO, MED REL G75446545 H5427621

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention