BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM

    MDR report key: 12046924 · Received June 22, 2021

    Report

    Report Number
    2027467-2021-00041
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 24, 2021
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    UDI-DI
    00844856067134
    PMA / PMN Number
    K102820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: YES. H6: MEDICAL DEVICE PROBLEM:2907. MEDICAL DEVICE COMPONENT: 907. TYPE OF INVESTIGATION: 10; 3331. INVESTIGATION FINDINGS:4248. INVESTIGATION CONCLUSION: 19. H10: THE IMPLANT WAS RECEIVED, AND A VISUAL INSPECTION WAS CONDUCTED WHICH CONFIRMED THE MIDDLE BLOCKING SLIDE HAD BECOME COMPLETELY DETACHED FROM THE IMPLANT. THE PLATE CONTAINS A WITNESS MARK ON THE POSTERIOR SIDE DIRECTLY BEHIND THE LOCATION OF THE DETACHED BLOCKING SLIDE. THE WITNESS MARK SUGGESTS THE PLATE BENDING INSTRUMENT WAS POSITIONED INCONSISTENT WITH IFU REQUIREMENTS WHILE CONTOURING/BENDING THE PLATE. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THIS PN/LN. QTY 9 PLATES WERE RECEIVED ON 04/02/2012 MANUFACTURED TO DRAWING REV. C. THE PLATES MET ALL SPECIFICATION REQUIREMENTS AND PASSED FINAL INSPECTION PRIOR TO BEING RELEASED INTO INVENTORY. NO PATIENT INJURY WAS REPORTED. ROOT CAUSE APPEARS TO BE THE RESULTS OF AN INCORRECT PLATE BENDING TECHNIQUE. WITNESS MARKS CONFIRM THE PLATE BENDING INSTRUMENT WAS POSITIONED INCONSISTENT WITH SURGICAL TECHNIQUE GUIDE REQUIREMENTS WHILE CONTOURING/BENDING THE PLATE.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE IS CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE LOCKING MECHANISM POPPED OFF OF A 60MM TRESTLE LUXE PLATE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943729 TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC 71003-060 646047 00844856067134

    Patients

    Seq Age Sex Outcome Treatment
    1