BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 3738681 · Received April 10, 2014

    Report

    Report Number
    1030489-2014-02143
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS : VISUALLY CONFIRMED PRE-FIXATION PIN IS BROKEN; THE BROKEN OFF PORTION OF THE PIN IS MISSING AND WAS NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION APPEARS TO SHOW FAIRLY DUCTILE FRACTURE. SEM ANALYSIS APPEARS TO SHOW HELICAL FRACTURE WITH CIRCULAR MATERIAL FLOW WITH SHAFT ANGULATION, SUGGESTING TORSIONAL OVERLOAD WITH BENDING COMPONENT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : HOSPITAL. ALTHOUGH IT WAS REPORTED THAT NO MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED DEATH, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOTIC MYELOPATHY UNDERWENT AN ANTERIOR CERVICAL FUSION AND POSTERIOR DE COMPRESSION AT C4-C5. THE PATIENT WAS REPORTEDLY AFFECTED WITH SEVERE BONE SCLEROSIS AND THE BONE WAS VERY HARD. THE PROCEDURE REPORTEDLY LASTED 9 HOURS. A PREFIXATION PIN WAS INSERTED AT C5 AFTER IMPLANTING ALL FOUR SCREWS BUT COULD NOT BE SUCCESSFULLY REMOVED FROM THE CONSTRUCT. PLIERS WERE USED AT RETRIEVE THE PIN BUT THE TIP OF THE PIN BROKE. THE TIP FRAGMENT WAS DEEMED IRRETRIEVABLE AND WAS LEFT IN THE C5 VERTEBRA. THE SURGICAL TIME WAS EXTENDED 15 MINUTES DUE TO THE INCIDENT. NO PATIENT INJURY WAS REPORTED DURING THE IMMEDIATE POST-OP PERIOD. IT WAS THEN REPORTED THAT 2 DAYS AFTER THE SURGERY, "THE PATIENT¿S CONDITION SHARPLY DETERIORATED AND BECAME BRAIN DEAD ASSOCIATED WITH SUBARACHNOID HEMORRHAGE AND SUBSEQUENTLY DIED" THIRTEEN DAYS POST-OP. POSTOPERATIVELY, THE PATIENT AWOKE FROM GENERAL ANESTHESIA WITHOUT ANY PROBLEMS AND VITALS WERE STABLE. THE PATIENT WAS REPORTEDLY WELL UNTIL 2 DAYS POST-OP AND WAS ABLE TO WALK, "HOWEVER ON THAT DAY, THE PATIENT'S AIRWAY SEEMED TO BE STUCK WITH SOMETHING AND BECAME BRAIN DEAD IN SPITE OF RESUSCITATION ATTEMPTS". ACCORDING TO THE REPORT, THERE WERE "NO INTRAOPERATIVE ABNORMALITIES SEEN WITH THE PATIENT'S VITALS" NOR ANY "ABNORMAL BLEEDING" INTRAOPERATIVELY. IT WAS UNKNOWN WHAT CAUSED THE SHARP DETERIORATION OF THE CONDITION POST-OPERATIVELY. THE PHYSICIAN STATED THAT THE BRAIN DEATH WAS DUE TO STRESS CAUSED BY ANTERIOR AND POSTERIOR FUSION AND WAS NOT RELATED TO THE PRODUCTS. NO FURTHER INFORMATION IS EXPECTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217208 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT PIN, FIXATION, SMOOTH LXH MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Other CERVICAL PLATE