BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 12055962 · Received June 24, 2021

    Report

    Report Number
    1030489-2021-00841
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    August 17, 2020
    Report Date
    June 24, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEAN AGE WAS 68.1 YEARS (RANGE 30-83 YEARS). 18 MALE AND 42 FEMALE. COUNTRY: (B)(6). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RYO TAMAKI, KEIJI WADA, KEN OKAZAKI "SURGICAL TECHNIQUE AND ACCURACY OF S2 ALAR-ILIAC SCREW INSERTION USING INTRAOPERATIVE O-ARM NAVIGATION: AN ANALYSIS OF 120 SCREWS" WORLD NEUROSURG. (2020) 144:E326-E330 SUMMARY : THIS STUDY WAS FOR THE EVALUATION THE SURGICAL TECHNIQUE AND ACCURACY OF SAI SCREW PLACEMENT USING THE O-ARM. THIS STUDY INVOLVED 60 PATIENTS WHO UNDERWENT SAI SCREW PLACEMENT USING THE O-ARM SYSTEM BETWEEN SEPTEMBER 2013 AND SEPTEMBER 2019. THESE SURGERIES WERE PERFORMED BY 5 DIFFERENT SURGEONS. FOR O-ARM-BASED SAI SCREW INSERTION, A REFERENCE FRAME WAS ATTACHED TO THE SPINOUS PROCESS OF THE LOWER LUMBAR SPINE (USUALLY L4) SO AS NOT TO INTERFERE WITH SAI SCREW INSERTION AND TO FACILITATE SIMULTANEOUS L5-S POSTERIOR INTERBODY FUSION WITH NAVIGATION. THE NAVIGATED PROBE, ILIAC TAP, AND SCREWDRIVER WERE USED FOR SAI SCREW INSERTION. SCREW PLACEMENT ACCURACY AND SCREW LENGTH WERE ASSESSED USING POSTOPERATIVE COMPUTED TOMOGRAPHY. THE SCREW PLACEMENT WAS DEFINED AS ACCURATE IF THE SCREW DID NOT BREACH ANY CORTEX OF THE SACRAL OR ILIAC BONE. PERIOPERATIVE COMPLICATIONS WERE ALSO EVALUATED. REPORTED EVENT: MEAN AGE AT SURGERY WAS 68.1 (RANGE, 30E83) YEARS. A TOTAL OF 120 SAI SCREWS WERE PLACED. THE DIAMETER OF ALL SCREWS WAS 7.5 OR 8.5 MM. MEAN SCREW LENGTH WAS 82.8 MM: 42 WERE 90 MM, 71WERE 80 MM, 6 WERE 70 MM, AND 1 WAS 60 MM. TWO OF THE 120 (1.7%) SCREWS WERE MISPLACED, BREACHING THE LATERAL EDGE OF THE ANTERIOR SACRAL CORTEX. RATE OF ACCURATE SCREW PLACEMENT WAS 98.3% (118/120 SCREWS). THERE WERE NO SIGNIFICANT NEUROVASCULAR OR VISCERAL COMPLICATIONS PERIOPERATIVELY. NO COMPLICATIONS RELATED TO SCREW PLACEMENT WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955706 UNKNOWN THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_SCREW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR