BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIX-REVOLUTION ACP SYSTEM

    MDR report key: 3101420 · Received April 30, 2013

    Report

    Report Number
    2031966-2013-00024
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K093804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RADIOGRAPHS CONFIRMED THAT TWO INFERIOR BONE SCREWS ON THE PLATE WERE FRACTURED. REVISION SURGERY OCCURRED ON (B)(6) 2013 IN WHICH THE FRACTURED SCREWS WERE REMOVED AND ANOTHER TWO WERE PLACED TO COMPLETE TREATMENT. EXPLANTED SCREWS HAVE NOT BEEN RETURNED TO NUVASIVE FOR EVALUATION. INFORMATION SUGGESTS THAT UNION HAD NOT OCCURRED AT THE TIME OF THE FRACTURE. PT ACTIVITY AT THE TIME OF THE EVENT MAY HAVE CAUSED A CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THE FAILURE REMAINS UNKNOWN. REVIEW OF LABELING NOTES: WARNINGS CAUTIONS AND PRECAUTIONS: "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY." "... LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT."

    Description of Event or Problem · 1

    INITIAL SURGERY OCCURRED ON (B)(6) 2013 INVOLVING A THREE LEVEL ACDF AT C4-C7. ON (B)(6) 2013, PT WAS REACHING UP AND TWISTING WITH BOTH ARMS WHEN HE FELT A PAIN IN HIS NECK, WHICH RESULTED IN SORENESS. ADDITIONALLY IT WAS REPORTED THAT HE DID NOT HAVE ANY RADIATING PAIN IN HIS ARMS. HE ALSO HAD NO OTHER INJURIES. PT WAS OTHERWISE COMPLIANT WITH POST OPERATIVE CARE. REPORTEDLY, TWO 17 MM FIXED SCREWS (INFERIOR) OF THE EIGHT SCREWS, FRACTURED. REVISION SURGERY OCCURRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188112 HELIX-REVOLUTION ACP SYSTEM SPINAL INT VERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention