BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL

    MDR report key: 21720462 · Received March 28, 2025

    Report

    Report Number
    3012120772-2025-00010
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Report Date
    May 22, 2025
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    KWQ
    UDI-DI
    10889981278847
    PMA / PMN Number
    K212139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED SCREW HAD FRACTURED APPROXIMATELY IN HALF; ONLY THE TOP PORTION WAS RETURNED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION; NO RESPONSE WAS RECEIVED. IT IS UNKNOWN IF THE REMAINDER OF THE SCREW WAS LEFT IMPLANTED. THE OUTCOME OF THE INVESTIGATION IS STILL PENDING. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS LOOSENING OF SPINAL FIXATION IMPLANTS MAY OCCUR DUE TO INADEQUATE INITIAL FIXATION, LATENT INFECTION, AND/OR PREMATURE LOADING, POSSIBLY RESULTING IN BONE EROSION, MIGRATION, OR PAIN.

    Additional Manufacturer Narrative · 0

    UPDATE TO H3: DEVICE EVALUATED BY MANUFACTURER CHANGED TO "YES". UPDATE TO ADVERSE EVENT PROBLEM CODES. INVESTIGATION: PHYSICAL EVALUATION OF THE SCREW OBSERVED DISTAL TIP SHEARED OFF ABOUT HALFWAY DOWN THE SCREW SHANK. HOWEVER, IT IS UNCLEAR IF THAT WAS A RESULT OF THE REMOVAL WORKFLOW OR IF THAT FRACTURE OCCURRED IN-SITU. ADDITIONALLY, THE SCREW WAS RETURNED WITH AN AP1-210034 CERVICAL PLATE, 2 LEVEL, 34MM. UPON INVESTIGATION IT WAS CONFIRMED THAT THE LOCKING COVER ON THE INFERIOR RIGHT SIDE OF THE PLATE WAS BROKEN. THIS BROKEN LOCKING COVER CORRESPONDED WITH THE SCREW THAT HAD BACKED OUT ON THE X-RAY IMAGE PROVIDED. REPORT 3012120772-2025-00033 WAS CREATED TO DOCUMENT THE POTENTIAL AP1-210034 CERVICAL PLATE, 2 LEVEL, 34MM POST-OPERATIVE FRACTURE. ROOT CAUSE: UPON REVIEW OF THE INDEX SURGERY, IT WAS OBSERVED THAT THE SURGEON USED A SHORELINE SYSTEM DRILL TO COMPLETE THE SCREW HOLE PREPARATION STEP FOR THE RELATED ADMIRAL PLATE. THIS IS OFF-LABEL USE OF THE SHORELINE DRILL AS THE DESIGN IS INTENDED FOR THE STANDARD 3.5MM SCREWS IN THE SHORELINE SYSTEM, NOT THE STANDARD 4.0MM SCREWS IN THE ADMIRAL SYSTEM. THE REDUCED DRILL FLUTE DIAMETER MEANS THAT THE ADMIRAL SCREWS MUST DISPLACE ABOUT 6% MORE BONE DURING SCREW INSERTION, WHICH ADDS SHEAR STRESS TO THE SCREW WHILE CREATING THE PLATE CONSTRUCT. THIS CAN PREVENT THE SCREW FROM REACHING ITS INTENDED FULL SEAT IN THE PLATE POCKET AND CAN ATTRIBUTE TO MORE PRESSURE ON THE SCREWS IN THE CONSTRUCT POST-OPERATIVELY.

    Description of Event or Problem · 0

    ON 03 MAR 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF A SCREW BACKOUT ON AN ADMIRAL CERVICAL PLATE CONSTRUCT. THE PROVIDED X-RAY CORROBORATES THE REPORT. REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751567 ADMIRAL SCREW KWQ SEASPINE ORTHOPEDICS CORPORATION AP1-704016 DM1122352B 10889981278847

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention AP1-210034 CERVICAL PLATE, 2 LEVEL, 34MM