BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5955482 · Received September 16, 2016

    Report

    Report Number
    1030489-2016-02576
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 18, 2016
    Report Date
    February 22, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    MULTIPLE DEVICES WERE INVOLVED IN THE EVENT. ALTHOUGH IT IS UNKNOWN AS TO WHICH OF THE DEVICES LEAD TO THE EVENT, WE ARE REPORTING THIS INFO FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE USED: PART#: 7660020, LOT#: 0111926W, QTY: (B)(4), 510K# : K052187, UPN#: (B)(4). PART#: 7660020, LOT#: UNK, QTY: (B)(4), 510K#: K052187, UPN#: (B)(4). PART#: 7660020, LOT#: 0098242W, QTY: (B)(4), 510K#: K052187, UPN#: (B)(4). PART#: MSB_UNK_SET SCREW, LOT#: UNK, QTY: (B)(4), 510K#: UNK, UPN#: UNK. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: OPTICAL AND MICROSCOPIC EXAMINATION OF THE SET SCREWS IDENTIFIED SEVERE PITTING. MICROSCOPIC EXAMINATION IDENTIFIED CRYSTALLOGRAPHIC PITTING ON THE ROD INTERFACE SURFACE AND IN THE THREADS OF THE SET SCREWS, CONSISTENT IN LOCATION AND SURFACE MORPHOLOGY WITH CREVICE CORROSION. THE NATURE, LOCATION AND SURFACE MORPHOLOGY OF THE RETURNED IMPLANTS ARE CONSISTENT WITH ANTICIPATED IN-VIVO WEAR DUE TO CREVICE CORROSION. MULTIPLE DEVICES WERE INVOLVED IN THE EVENT. ALTHOUGH IT IS UNKNOWN AS TO WHICH OF THE DEVICES LEAD TO THE EVENT, WE ARE REPORTING THIS INFO FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE USED: PART# LOT# QTY MSB_UNK_SET SCREW UNK 7.

    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 THE PATIENT UNDERWENT POSTERIOR SPINE FUSION SURGERY FROM T12 TO L5. POST-OP, ON AN UNKNOWN DATE, IT WAS FOUND THAT THE PATIENT HAD DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS AND REQUIRED CORRECTIVE SURGERY FOR SAGITTAL IMBALANCE. IN THE REVISION SURGERY, EXTENSION OF IMPLANTS PROXIMAL TO T10 AND DISTAL TO S1 WAS DONE AND PEDICLE SUBTRACTION OSTEOTOMY AT L3 WAS PERFORMED. ALSO DURING THIS REVISION SURGERY, IT WAS FOUND THAT THE SET SCREWS AT T12 ON THE LEFT AND AT L5 ON THE RIGHT WERE NOT STRUCTURALLY INTACT AND APPEARED TO HAVE ERODED INTO THE SCREW HEAD. THE CONDITION OF THE REPORTED IMPLANTS WAS DISCOVERED ON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609296 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR