BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPHERXII MAS DEFORMITY SYSTEM

    MDR report key: 3267956 · Received July 31, 2013

    Report

    Report Number
    2031966-2013-00040
    Event Type
    Injury
    Date Received
    July 31, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 18, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K102514
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN 8801215 PRECEPT POLYAXIAL CANNULATED SCREW DRIVER WAS INVOLVED IN THE EVENT; IT WAS REPORTED TO HAVE AN OBSTRUCTED CANNULA. THE GUIDE WIRE MOST PROBABLY PASSED THROUGH THE VERTEBRAL BODY AND ENTERED THE ABDOMINAL CAVITY. DEPTH OF PENETRATION IS UNK. NO SEQUELAE RELATED TO THE EVENT ARE KNOWN TO HAVE OCCURRED. INSPECTION OF THE 8801215 DRIVER NOTED THE CANNULA WAS OBSTRUCTED BY RETAINED BIOMASS. PRIOR TO THIS SURGERY, THE SURGICAL TRAYS WERE INSPECTED BY NUVASIVE PERSONNEL AND NOTED TO BE ACCEPTABLE FOR USE. UPON RETURN OF THE INSTRUMENTS TO NUVASIVE, THE 8801215 DRIVER WAS CONFIRMED TO HAVE HAD BIOMASS IN THE CANNULA SUFFICIENT TO OBSTRUCT PASSAGE OF THE 8801069 GUIDE WIRE. THE PROXIMATE CAUSE OF THE REPORTED EVENT IS AN ATTEMPT TO RELIEVE THE OBSTRUCTION IN-SITU BY THE SURGEON. ROOT CAUSE OF THE EVENT IS THE OPERATOR FAILED TO CLEAN THE CANNULA AS SPECIFIED DURING INSPECTION.

    Description of Event or Problem · 1

    DURING PERCUTANEOUS PLACEMENT OF PEDICLE SCREWS, IT WAS NOTED THAT THE CANNULATED SCREW DRIVERS WOULD NOT PASS OVER THE GUIDE WIRE. DURING THE ATTEMPTS TO RELEASE THE BLOCKAGE AND PASS THE DRIVER OVER THE GUIDE WIRE, THE GUIDE WIRE PIERCED THE ABDOMINAL CAVITY. THE GUIDE WIRE WAS REMOVED AND THE SURGEON PROCEEDED TO INSERT THE SCREWS VIA THE EXISTING INCISION USING AN ALTERNATE DRIVER. THE WOUND WAS IRRIGATED WITH BETADINE SOLUTION AND VANCOMYCIN WAS APPLIED TO THE SITE. THE LEFT INCISION WAS CLOSED WITHOUT INCIDENT AND CONTRALATERAL SCREWS WERE IMPLANTED USING A SIMILAR INCISION; BETADINE/VANCOMYCIN COMPOUNDS WERE APPLIED AS WELL. AT THE CLOSE OF THE CASE THE PT REMAINED ANESTHETIZED AND AN ABDOMINAL CT SCAN WAS PERFORMED; NO ABDOMINAL INJURY WAS NOTED. ANESTHETIC WAS THEN REVERSED AND THE PT EXTUBATED BEFORE BEING TAKEN TO ICU FOR POST-OPERATIVE CARE. SUBSEQUENT CT SCAN AND PHYSICAL EXAMS YIELDED NO EVIDENCE OF ABDOMINAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358246 SPHERXII MAS DEFORMITY SYSTEM SPINAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC. 8801069 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention