BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLY BONE SCREW-L

    MDR report key: 8515345 · Received April 15, 2019

    Report

    Report Number
    3009394448-2019-00002
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 11, 2019
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC.
    Product Code
    OVE
    UDI-DI
    00852776006317
    PMA / PMN Number
    K163474
    Removal / Correction Number
    3009394448-19-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED PROBLEM DESCRIPTION FOR CLARITY. FROM: DURING COMPLETION OF A 3 LEVEL ACDF, C3-C6 , ON A 59-YEAR-OLD FEMALE, A SURGEON REPORTED MAL-POSITION OF THE SUPERIOR ALLY BONE SCREW-L THROUGH CAVUX-L CERVICAL CAGE AT C4-C5 LEVEL UPON DELIVERY AND ADJUSTMENT WITH A SCREW DRIVER WITHOUT USE OF THE CAGE HOLDER INSTRUMENT, RESULTING IN THE SCREW PROTRUDING BEYOND THE CAGE BY APPROXIMATELY 2 MILLIMETERS. THE SURGEON REMOVED THE SCREW AND REPLACED IT WITH ANOTHER SCREW, RESULTING IS A SUCCESSFUL PLACEMENT. SURGEON EXPERIENCED SIMILAR ISSUE AT THE C5-C6 LEVEL, BUT THE PROTRUSION BEYOND THE CAGE WAS MINIMAL, AND SURGEON DID NOT ADJUST THE SCREW POSITION. SURGEON REPORTED THAT OVERALL THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY NEGATIVE SEQUALAE. TO: DURING COMPLETION OF A 3 LEVEL ACDF, C3-C6 , ON A 59-YEAR-OLD FEMALE, A SURGEON REPORTED MAL-POSITION OF THE SUPERIOR ALLY BONE SCREW-L THROUGH CAVUX CERVICAL CAGE-L IMPLANT AT C4-C5 LEVEL UPON DELIVERY AND ADJUSTMENT WITH A SCREW DRIVER WITHOUT USE OF THE CAGE DELIVERY INSTRUMENT, RESULTING IN APPROXIMATELY 3MM OF EXCESS PROTRUSION FROM THE INTENDED SCREW PLACEMENT POSITION. THE SURGEON REMOVED THE SCREW AND REPLACED IT WITH ANOTHER SCREW, RESULTING IN A SUCCESSFUL PLACEMENT. SURGEON EXPERIENCED SIMILAR ISSUE AT THE C5-C6 LEVEL, BUT THE PROTRUSION BEYOND THE CAGE WAS MINIMAL, AND SURGEON DID NOT ADJUST THE SCREW POSITION. SURGEON REPORTED THAT OVERALL THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY NEGATIVE CLINICAL SEQUALAE.

    Description of Event or Problem · 0

    DURING COMPLETION OF A 3 LEVEL ACDF, C3-C6 , ON A 59-YEAR-OLD FEMALE, A SURGEON REPORTED MAL-POSITION OF THE SUPERIOR ALLY BONE SCREW-L THROUGH CAVUX CERVICAL CAGE-L IMPLANT AT C4-C5 LEVEL UPON DELIVERY AND ADJUSTMENT WITH A SCREW DRIVER WITHOUT USE OF THE CAGE DELIVERY INSTRUMENT, RESULTING IN APPROXIMATELY 3MM OF EXCESS PROTRUSION FROM THE INTENDED SCREW PLACEMENT POSITION. THE SURGEON REMOVED THE SCREW AND REPLACED IT WITH ANOTHER SCREW, RESULTING IN A SUCCESSFUL PLACEMENT. SURGEON EXPERIENCED SIMILAR ISSUE AT THE C5-C6 LEVEL, BUT THE PROTRUSION BEYOND THE CAGE WAS MINIMAL, AND SURGEON DID NOT ADJUST THE SCREW POSITION. SURGEON REPORTED THAT OVERALL THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY NEGATIVE CLINICAL SEQUALAE.

    Additional Manufacturer Narrative · 1

    THE SCREW MALPOSITION OCCURRED DUE TO THE USE OF AN UNDERSIZED SCREW, EXACERBATED BY THE SURGEON OVER-DRIVING THE SCREW INTO THE CAGE WITHOUT USE OF THE CAGE HOLDER INSTRUMENT, WHICH IS SUPPLIED WITH THE KIT.

    Description of Event or Problem · 1

    DURING COMPLETION OF A 3 LEVEL ACDF, C3-C6 , ON A (B)(6) FEMALE, A SURGEON REPORTED MAL-POSITION OF THE SUPERIOR ALLY BONE SCREW-L THROUGH CAVUX-L CERVICAL CAGE AT C4-C5 LEVEL UPON DELIVERY AND ADJUSTMENT WITH A SCREW DRIVER WITHOUT USE OF THE CAGE HOLDER INSTRUMENT, RESULTING IN THE SCREW PROTRUDING BEYOND THE CAGE BY APPROXIMATELY 2 MILLIMETERS. THE SURGEON REMOVED THE SCREW AND REPLACED IT WITH ANOTHER SCREW, RESULTING IS A SUCCESSFUL PLACEMENT. SURGEON EXPERIENCED SIMILAR ISSUE AT THE C5-C6 LEVEL, BUT THE PROTRUSION BEYOND THE CAGE WAS MINIMAL, AND SURGEON DID NOT ADJUST THE SCREW POSITION. SURGEON REPORTED THAT OVERALL THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY NEGATIVE SEQUALAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309182 ALLY BONE SCREW-L INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE PROVIDENCE MEDICAL TECHNOLOGY, INC. PD-32-602 045647 00852776006317

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR CAVUX SPINAL SYSTEM-L, CAVUX CERVICAL CAGE-L| CAVUX SPINAL SYSTEM-L, CAVUX CERVICAL CAGE-L