BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 19177430 · Received April 24, 2024

    Report

    Report Number
    0009617544-2024-00049
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    August 1, 2015
    Report Date
    August 22, 2024
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE ARTICLE 'THE ACCURACY AND SAFETY OF FLUOROSCOPICALLY GUIDED PERCUTANEOUS PEDICLE SCREWS IN THE LUMBOSACRAL JUNCTION AND THE LUMBAR SPINE' IN THE BONE AND JOINT JOURNAL 2015; 97-B:1111¿17, WAS REVIEWED. THIS WAS A RETROSPECTIVE EVALUATION STUDY UNDERTAKEN IN TWO STUDY POPULATIONS INVOLVING 203 PATIENTS (MEAN AGE 58.8 YEARS; 16 TO 91, 103 MALE, 100 FEMALE) AND 880 LUMBOSACRAL JUNCTION AND LUMBAR PERCUTANEOUS PEDICLE SCREWS. SURGERIES WERE PERFORMED BETWEEN JANUARY 2008 AND DECEMBER 2012 IN CONSECUTIVE PATIENTS. MANTIS SYSTEMS WERE USED IN ALL CASES. SCREWS WITH PERFORATIONS WERE CLASSIFIED INTO TWO TYPES. FOR MEDIAL, LATERAL, SUPERIOR AND INFERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING GERTZBEIN AND ROBBIN¿S CLASSIFICATION AS MODIFIED BY RAO. FOR ANTERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING A MODIFIED GRADING SYSTEM. GRADE 2 PERFORATIONS WERE CONSIDERED TO HAVE POSSIBLE COMPLICATIONS AND GRADE 3 WERE CONSIDERED CRITICAL PERFORATIONS WITH A HIGH RISK OF EARLY OR LATE COMPLICATIONS. THERE WERE A TOTAL OF 48 LATERAL PERFORATIONS, 22 ANTERIOR PERFORATIONS, 11 MEDIAL PERFORATIONS, 4 SUPERIOR PERFORATIONS AND 2 INFERIOR PERFORATIONS. ONE PATIENT (F, 57 YEARS OLD) WAS DIAGNOSED WITH GRADE II L4/5 SPONDYLOLISTHESIS. A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) WAS PERFORMED. THE LEFT L5 PEDICLE SCREW SHOWED GRADE 3 MEDIAL PERFORATION ON THE POST-OPERATIVE CT SCANS. SHE DEVELOPED POSTOPERATIVE NERVE ROOT IRRITATION CAUSING RADICULAR PAIN FROM THE GLUTEAL TO THE LATERAL ASPECT OF THE LEFT LEG, WHICH SUBSIDED WITH MEDICATIONS. NO REVISION SURGERY WAS CARRIED OUT.

    Description of Event or Problem · 0

    THE ARTICLE 'THE ACCURACY AND SAFETY OF FLUOROSCOPICALLY GUIDED PERCUTANEOUS PEDICLE SCREWS IN THE LUMBOSACRAL JUNCTION AND THE LUMBAR SPINE' IN THE BONE AND JOINT JOURNAL 2015; 97-B:1111¿17, WAS REVIEWED. THIS WAS A RETROSPECTIVE EVALUATION STUDY UNDERTAKEN IN TWO STUDY POPULATIONS INVOLVING (B)(4) PATIENTS (MEAN AGE 58.8 YEARS; 16 TO (B)(6)) AND (B)(4) LUMBOSACRAL JUNCTION AND LUMBAR PERCUTANEOUS PEDICLE SCREWS. SURGERIES WERE PERFORMED BETWEEN (B)(6) 2008 AND (B)(6) 2012 IN CONSECUTIVE PATIENTS. MANTIS SYSTEMS WERE USED IN ALL CASES. SCREWS WITH PERFORATIONS WERE CLASSIFIED INTO TWO TYPES. FOR MEDIAL, LATERAL, SUPERIOR AND INFERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING GERTZBEIN AND ROBBIN¿S CLASSIFICATION AS MODIFIED BY (B)(4). FOR ANTERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING A MODIFIED GRADING SYSTEM. GRADE 2 PERFORATIONS WERE CONSIDERED TO HAVE POSSIBLE COMPLICATIONS AND GRADE 3 WERE CONSIDERED CRITICAL PERFORATIONS WITH A HIGH RISK OF EARLY OR LATE COMPLICATIONS. THERE WERE A TOTAL OF (B)(4) LATERAL PERFORATIONS, (B)(4) ANTERIOR PERFORATIONS, (B)(4) MEDIAL PERFORATIONS, (B)(4) SUPERIOR PERFORATIONS AND (B)(4) INFERIOR PERFORATIONS. ONE PATIENT (F, 57 YEARS OLD) WAS DIAGNOSED WITH GRADE II L4/5 SPONDYLOLISTHESIS. A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF) WAS PERFORMED. THE LEFT L5 PEDICLE SCREW SHOWED GRADE 3 MEDIAL PERFORATION ON THE POST-OPERATIVE CT SCANS. SHE DEVELOPED POSTOPERATIVE NERVE ROOT IRRITATION CAUSING RADICULAR PAIN FROM THE GLUTEAL TO THE LATERAL ASPECT OF THE LEFT LEG, WHICH SUBSIDED WITH MEDICATIONS. NO REVISION SURGERY WAS CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854987 UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other