BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 9511906 · Received December 23, 2019

    Report

    Report Number
    1526439-2019-52758
    Event Type
    Injury
    Date Received
    December 23, 2019
    Report Date
    November 28, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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). 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: KHAN, J.A., AND BAJRACHARYA, A.R. (2007), SURGICAL TREATMENT OF ISTHMIC SPONDYLOLISTHESIS WITH RADICULAR PAIN IN ADULTS, JOURNAL OF THE NEPAL MEDICAL ASSOCIATION, VOL. 46, NO. 4, ISSUE 168, PAGES 170-174 (NEPAL). THE AIM OF THIS STUDY WAS TO SEE THE OUTCOME OF STABILIZATION AND ARTHRODESIS WITHOUT DECOMPRESSION. FROM 2003 TO 2007, A TOTAL OF 8 FEMALE PATIENTS WITH A MEAN AGE OF 50.6 (RANGE: 43-55) YEARS WERE TREATED WITH A MOSS MIAMI INSTRUMENTATION. THE FOLLOW UP PERIOD WAS RANGED FROM 12 TO 36 MONTHS. FOLLOW UP EVALUATION WAS DONE AT 3, 6, 12, 24 AND 36 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD A RECURRENT BACK ACHE WHICH SHOWED SEVERE DEGENERATIVE CHANGES AT L2 AND L3 LEVEL. 1 PATIENT HAD POSTOPERATIVE CONSTANT BACK PAIN. 2 PATIENTS HAD POSTOPERATIVE EPISODIC BACK PAIN. 1 PATIENT DEVELOPED SUPERFICIAL WOUND INFECTION THAT SUBSEQUENTLY HEALED WITH DRESSINGS AND INTRAVENOUS ANTIBIOTICS. 2 PATIENTS COMPLAINED OF HYPOESTHESIA IN THE BUTTOCK, PROBABLY DUE TO INJURY TO SUPERIOR CLUNEAL NERVES WHILE HARVESTING THE GRAFT. 4 PATIENTS HAD PAIN AT THE DONOR SITE THAT LASTED A MONTH. THIS REPORT IS FOR A MOSS MIAMI INSTRUMENTATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304758 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention