BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 9444268 · Received December 10, 2019

    Report

    Report Number
    1526439-2019-52648
    Event Type
    Injury
    Date Received
    December 10, 2019
    Report Date
    November 15, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. (B)(4) ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED, PARAESTHESIA, DURAL TEAR. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TITLE: FUNCTIONAL OUTCOMES OF INSTRUMENTED POSTERIOR LUMBAR INTERBODY FUSION IN ACTIVE-DUTY US SERVICEMEN: A COMPARISON WITH NONOPERATIVE MANAGEMENT. CITATION: THE SPINE JOURNAL 1 (2001) 215¿224 (USA). THE PURPOSE OF THIS STUDY IS TO EVALUATE THE EFFECTIVENESS OF TWO VERY DIFFERENT TREATMENT METHODS FOR PHYSICALLY ACTIVE INDIVIDUALS WITH CHRONIC BACK PAIN RELATED TO SINGLE-LEVEL LUMBAR DISC DEGENERATION. FROM AUGUST 1998 TO MARCH 2000, 29 ACTIVE-DUTY US MILITARY MALE PERSONNEL WITH AVERAGE AGE 36 YEARS (RANGE, 25¿42 YEARS) WERE TREATED FOR CHRONIC BACK PAIN AND SINGLE-LEVEL LUMBAR DISC DEGENERATION. FIFTEEN PATIENTS WERE TREATED OPERATIVELY WITH INSTRUMENTED POSTERIOR LUMBAR INTERBODY FUSION SURGERY USING AUTOGENOUS ILIAC CREST BONE GRAFT, NONTHREADED INTERBODY FUSION CAGES (BRANTIGAN OR HARMS), AND A FOUR-PEDICLE SCREW/ ROD INSTRUMENTATION CONSTRUCT (MOSS MIAMI, ISOLA, OR SYNTHES). A CONCOMITANT POSTEROLATERAL FUSION WAS PERFORMED IN ALL 15 CASES. FOURTEEN PATIENTS REFUSED SURGICAL TREATMENT AND CHOSE TO BE TREATED NONOPERATIVELY. THESE PATIENTS WERE TREATED WITH A SPECIFIC 8-WEEK NONOPERATIVE TREATMENT PLAN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1- NONTHREADED INTERBODY FUSION CAGES (HARMS), 4 - PEDICLE SCREW/ROD INSTRUMENTATION CONSTRUCT. INTRAOPERATIVE DURAL TEAR - N=2, TRANSIENT UNILATERAL LOWER EXTREMITY PARESTHESIA - N=1, POSTERIOR PSEUDARTHROSIS - N=4. MOSS MIAMI PRODUCTS WERE USED AS A PART OF THIS STUDY. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241742 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention