BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: VIPER 2

    MDR report key: 14241118 · Received April 28, 2022

    Report

    Report Number
    1526439-2022-00631
    Event Type
    Injury
    Date Received
    April 28, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN SCREWS: VIPER 2. /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BARBAGALLO G.M.V., ET AL (2015) MULTILEVEL MINI-OPEN TLIFS AND PERCUTANEOUS PEDICLE SCREW FIXATION: DESCRIPTION OF A SIMPLE TECHNICAL NUANCE USED TO INCREASE INTRAOPERATIVE SAFETY AND IMPROVE WORKFLOW. TIPS AND TRICKS AND REVIEW OF THE LITERATURE, NEUROSURG REV VOLUME 38, PAGES 343¿354 (ITALY). THIS STUDY AIMS TO REPORT OUR EXPERIENCE AND TECHNIQUE FOR MULTILEVEL MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MI-TLIFS) AND PERCUTANEOUS PEDICLE SCREW FIXATION TECHNIQUE.THIRTEEN PATIENTS (NINE FEMALES), AGED 50 TO 79 (MEAN AGE 66.8) YEARS, WERE DIAGNOSED WITH MULTILEVEL DEGENERATIVE DISC DISEASE (DDD) CAUSING LOW-BACK PAIN, NEUROGENIC INTERMITTENT CLAUDICATION (NIC), AND/OR RADICULOPATHY UNDERWENT MULTILEVEL PEDICLE SCREW FIXATION (PPSF) AND MINI-OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION (M-TLIFS) (M-TLIF) (ONE TO FOUR LEVELS). ALL PATIENTS WERE OPERATED ON USING A TECHNICAL VARIANT, NAMED KIRSCHNER CAGE SCREW (KCS) TECHNIQUE, USING BULLET-SHAPED CARBON FIBER REINFORCED POLYMER (CFRP) OR POLYETHERETHERKETONE (PEEK) CAGE PACKED WITH AUTOLOGOUS OR SILICATE SUBSTITUTED CALCIUM PHOSPHATE (ACTIFUSE ABX; BAXTER) BONE GRAFT AND PEDICLE SCREWS (VIPER2, DEPUY SPINE; JOHNSON&JOHNSON) WERE INSERTED PERCUTANEOUSLY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: ACCORDING TO THE GRADING PROPOSED BY KIM ET AL., TWO SCREWS HAD ENCROACHMENT OF THE MEDIAL PEDICULAR CORTEX. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE PEDICLE SCREWS (VIPER2). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119433 UNK - SCREWS: VIPER 2 ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention