BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL ACP SYSTEM

    MDR report key: 17372661 · Received July 21, 2023

    Report

    Report Number
    3012120772-2023-00014
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 21, 2023
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    KWQ
    UDI-DI
    10889981276935
    PMA / PMN Number
    K212139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AP2-100506 TEMPORARY FIXATION PIN (REPORT #3012120772-2023-00013) AND AP2-100314 ADMIRAL ACP DRILL WERE NOT RETURNED FOR ANALYSIS; HOWEVER, REVIEW OF THE X-RAYS PROVIDED CONFIRMS FRAGMENTS OF THE DRILL AND TEMPORARY FIXATION PIN REMAIN IN THE SURGICAL SITE. ADDITIONAL DETAIL REGARDING THE SURGICAL TECHNIQUE AND/OR PATIENT'S ANATOMY HAS NOT BEEN MADE AVAILABLE FOR CONSIDERATION. A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. REVIEW OF QF-10-01 ADMIRAL ACP SYSTEM IFU: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY, OR FRACTURE OF COMPONENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S ADMIRAL ACP SYSTEM. DURING THE PROCEDURE, AN AP2-100506 TEMPORARY FIXATION PIN WAS INSERTED THROUGH A SCREW HOLE; THE TEMPORARY FIXATION PIN WAS THEN REMOVED WITHOUT BEING AWARE THAT THE PIN HAD FRACTURED AND A FRAGMENT WAS LEFT IN THE SURGICAL SITE. THE SURGEON CONTINUED THROUGH THE PROCEDURE BY INSERTING AN AP2-100314 ADMIRAL ACP DRILL, 14MM INTO THE SAME SCREW HOLE. THE ACP DRILL MADE CONTACT WITH THE TEMPORARY FIXATION PIN AND CREATED ENOUGH FRICTION TO CAUSE IT TO FRACTURE AS WELL. FRAGMENTS OF BOTH THE AP2-100506 TEMPORARY FIXATION PIN AND THE AP2-100314 ACP DRILL REMAIN IN-SITU. NO REPORTS OF TISSUE DAMAGE OR PATIENT INJURY WAS REPORTED AND THERE ARE NO PLANS FOR REVISION OR REMOVAL AT THIS TIME. SEASPINE WAS MADE AWARE OF THIS INCIDENT ON (B)(6)2023. REPORT #3012120772-2023-00013 AP2-100506 TEMPORARY FIXATION PIN REPORT AP2-100314 ACP DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148151 ADMIRAL ACP SYSTEM ADMIRAL ACP DRILL, 14MM KWQ SEASPINE ORTHOPEDICS CORPORATION AP2-100314 10889981276935

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other SHORELINE RT| VUMESH