BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6753449 · Received July 31, 2017

    Report

    Report Number
    1030489-2017-01834
    Event Type
    Injury
    Date Received
    July 31, 2017
    Report Date
    July 4, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    REFER H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958730PT, 510K # K143471 WAS CLEARED IN THE UNITED STATES. : PATIENT CODE: C64343 (REVISION SURGERY). 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. 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 ON AN UNKNOWN DATE, PATIENT UNDERWENT POSTERIOR DECOMPRESSION FUSION AT C1-2. POST-OP, SCREW LOOSENING AND RECURRENCE OF NEUROLOGICAL SYMPTOM WERE DEVELOPED AS COMPLICATION. SO, ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY. IMPLANTS AT THE AREA OF C1-2 WERE REMOVED AND THE ANCHORING WAS CONDUCTED FROM OCCIPITAL BONE TO C2/C3, AND THEN POSTERIOR FUSION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535149 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention