BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 9880134 · Received March 25, 2020

    Report

    Report Number
    1526439-2020-00757
    Event Type
    Injury
    Date Received
    March 25, 2020
    Report Date
    February 27, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PATIENT INVOLVED IN THE STUDY. IMPLANTATION DATE: UNKNOWN. 510K: 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VISOCCHI M., SIGNORELLI F., OLIVI A., CALDARELLI M., (2019) WIRING OR SCREWING AT THE CRANIOVERTEBRAL JUNCTION IN CHILDHOOD: PAST AND PRESENT PERSONAL EXPERIENCE, ACTA NEUROCHIRURGICA SUPPLEMENT, VOL. 125, PAGES 253-258 (ITALY). THIS STUDY AIMS TO PRESENT AN UPDATE OF OUR PERSONAL EXPERIENCE OF INSTRUMENTATION AND FUSION IN CHILDREN, USING TITANIUM RODS, SUBLAMINAR WIRES, AND SCREWS. FROM 1998 TO 2018, A TOTAL OF 12 CHILDREN WITH IRREDUCIBLE NEOPLASTIC, DYSEMBRYOGENETIC, INFLAMMATORY AND CHRONIC TRAUMATIC DISEASES OF THE ANTERIOR CRANIOVERTEBRAL JUNCTION (CVJ) WERE INCLUDED IN THE STUDY. SIX FEMALE PATIENTS AGED 6¿14 YEARS (MEAN AGE 9.5 YEARS) HARBORING A CONGENITAL INSTABILITY ASSOCIATED WITH DOWN¿S OR MORQUIO¿S SYNDROMES AND PRIMARY OS ODONTOIDEUM WERE TREATED FOR OS ODONTOLITE (GROUP 1). A SECOND GROUP (GROUP 2), CONSISTING OF SIX MALE PATIENTS AGED 8¿15 YEARS (MEAN AGE 11.5 YEARS), WITH ACQUIRED IATROGENIC INSTABILITY DUE TO TRANSORAL ANTERIOR DECOMPRESSION FOR DIFFERENT REASONS (INFERIOR CLIVECTOMY, ANTERIOR ARCH REMOVAL, AND ODONTOIDECTOMY)UNDERWENT TRANSORAL ANTERIOR DECOMPRESSION AND STAGED POSTERIOR INSTRUMENTATION AND FUSION WITH SCREWS: C0¿C2¿C3 SCREWS 3.5 MM IN DIAMETER AND 12 MM IN LENGTH (VERTEX SYSTEM [MEDTRONIC, MINNEAPOLIS, MN, USA]; SUMMIT SI OCT SPINAL FIXATION SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM [DEPUY SYNTHES SPINE, WARSAW, IN, USA]; AND VUEPOINT OCT [NUVASIVE, SAN DIEGO, CA, USA]), FOR DIFFERENT DISEASES. RADIOLOGICAL AND CT SCANS PLUS MRI AND NEUROLOGICAL EXAMINATIONS WERE PERFORMED 1 WEEK AFTER SURGERY, THEN EVERY 4 MONTHS UP TO 1 YEAR AND FINALLY AT THE LAST FOLLOW-UP. THE FOLLOW-UP PERIOD RANGED FROM 63 TO 202 MONTHS (MEAN 118.5 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: NEURORADIOLOGICAL SIGNS OF BONE FUSION WERE ALREADY EVIDENT 4 MONTHS AFTER SURGERY IN ALL BUT TWO PATIENTS. LONG-LASTING INFECTION, WHICH OCCURRED IN ONE OF THE PATIENTS. (GROUP 2). A CASE OF AN (B)(6) YEAR-OLD MALE (#10) THE HARDWARE WAS REVISED, AND THE SYNTHETIC BONE GRAFT SUBSTITUTE WAS REMOVED 2 WEEKS AFTER THE STAGED INSTRUMENTATION AND FUSION PROCEDURE, BECAUSE OF INFECTIVE DEHISCENCE OF THE SURGICAL WOUND. AFTER 2 MONTHS OF POLYANTIBIOTIC THERAPY AND 1 MONTH AFTER COLLAR REMOVAL, A DYNAMIC CERVICAL MRI EXAMINATION CONFIRMED CVJ STABILITY. (GROUP 2). THIS REPORT IS FOR AN UNKNOWN SYNTHES SUMMIT SI OCT SPINAL FIXATION SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM . THIS IS 1 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342006 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention