BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIX-REVOLUTION ACP SYSTEM

    MDR report key: 3736645 · Received April 3, 2014

    Report

    Report Number
    2031966-2014-00021
    Event Type
    Other
    Date Received
    April 3, 2014
    Date of Event
    March 6, 2011
    Report Date
    April 3, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K093804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RADIOGRAPH CONFIRMED THE REPORTED EVENT. RETURNED DEVICES WERE MEASURED AND MET DESIGN REQUIREMENTS. EVALUATION OF THE DEVICES CONFIRMED THE DEVICES WERE IMPLANTED AND HAD MINOR WEAR. REVIEW OF THE DEVICE HISTORY RECORDS NOTES NO MATERIAL NON-CONFORMANCES OR MANUFACTURING ERRORS THAT THEY MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE. PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT IS UNK. PATIENT'S BONE QUALITY WAS UNK. IT IS UNK IF THE PATIENT HAD A FAILURE TO FUSE PRIOR TO THE SCREW BACK OUT. THE ROOT CAUSE OF THE ISSUE REMAINS UNK. REVIEW OF LABELING NOTES: WARNINGS CAUTIONS AND PRECAUTIONS: PRODUCT LABELING INDICATES"... POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADD'L SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY."

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT AN INFERIOR CERVICAL BONE SCREW BACKED OUT OF A ONE LEVEL, (C7-T1) ACDF PLATE AT T1. REVISION OCCURRED ON (B)(6) 2014 TO REMOVE THE PLATE AND SCREWS AND PLACED ANOTHER SINGLE LEVEL PLATE ABOVE AT C6-C7. PATIENT IS REPORTEDLY DOING WELL POST REVISION. ORIGINAL SURGERY DATE WAS (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203514 HELIX-REVOLUTION ACP SYSTEM SPINAL INT VERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7803113 BB3335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention