BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX® RECONSTRUCTION SYSTEM

    MDR report key: 6412859 · Received March 17, 2017

    Report

    Report Number
    1030489-2017-00566
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 20, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    REFER H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 7755279 AND 510K# K123656 AND (B)(4) IS APPROVED FOR SALE IN THE US. (B)(4). 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 PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS ATLANTOAXIAL SUBLUXATION. FOR WHICH, ON (B)(6) 2015, PATIENT UNDERWENT CERVICAL POSTERIOR FUSION SURGERY AT LEVEL C7. REPORTEDLY, ON (B)(6) 2017, POST-OP, THE PART OF THE PLATE HOLDING THE ROD INTERFERED SKIN AND CAUSED BEDSORES. THE PATIENT ACHIEVED SOLID FUSION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY FOR CLEANING OF THE PART OF BEDSORES. ANTIBIOTIC WAS PRESCRIBED TO THE PATIENT. ROD AND SCREWS WERE REPORTED TO BE NON DEFECTIVE. ONLY OCCIPITOCERVICAL (OC) PLATE AND OC SCREWS WERE EXPLANTED WITH CRANIAL PART OF THE ADJUSTABLE RODS WHICH WERE DISASSEMBLED AT MOVING PARTS. THE PLATE PERFORATED THE SKIN. THE PLATE DID NOT MIGRATE. THE SURGEON COMMENTED THAT THERE WAS NO POSSIBILITY TO HAVE BEDSORE AT THE TIME WHEN HE PERFORMED THE SURGERY. THE SURGEON THINKS THAT CHANGE OF THE PATIENT'S BODY SHAPE MIGHT HAVE CAUSED THE BEDSORE. PATIENT'S RECOVERY IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194806 VERTEX® RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention