BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MONO/POLYAXIAL SCREWS

    MDR report key: 9539705 · Received January 2, 2020

    Report

    Report Number
    1526439-2020-00071
    Event Type
    Injury
    Date Received
    January 2, 2020
    Report Date
    December 6, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN MONO/ POLYAXIAL SCREWS/ 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. 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: INNOCENZI, G. ET AL (2017), DOES NAVIGATION IMPROVE PEDICLE SCREW PLACEMENT ACCURACY? COMPARISON BETWEEN NAVIGATED AND NON-NAVIGATED PERCUTANEOUS AND OPEN FIXATIONS, IN: VISOCCHI M., MEHDORN H.M., KATAYAMA Y., VON WILD K.R.H. (EDS) TRENDS IN RECONSTRUCTIVE NEUROSURGERY. ACTA NEUROCHIRURGICA SUPPLEMENT, VOL. 124, PAGES 289-295, DOI 10.1007/978-3-319-39546-3_42, (ITALY). THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY AND RELIABILITY OF AN OPEN FREE-HAND TECHNIQUE, AN OPEN NAVIGATED TECHNIQUE (BRAINLAB® SYSTEM), A PERCUTANEOUS CT-BASED NAVIGATION TECHNIQUE, AND A PERCUTANEOUS FLUOROSCOPY-GUIDED TECHNIQUE. BETWEEN JANUARY 2012 TO FEBRUARY 2014, A TOTAL OF 203 PATIENTS (88 MALE AND 115 FEMALE) UNDERWENT THORACIC AND LUMBAR FUSION WITH PERCUTANEOUS TECHNIQUES. SURGERY WAS PERFORMED USING VIPER 2 SYSTEM AND OPEN PEDICLE SCREW (EXPEDIUM 5.5 SYSTEM, DEPUY SPINE, RAYNHAM, MA). FOLLOW-UP PERIOD IS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: DIRECTION OF BREACHES IN LUMBAR VERTEBRAE ACCORDING TO SCREWS PLACEMENT: 10 SCREWS IN GROUP P WERE LATERAL AXIAL/ CORONAL; 6 SCREWS IN GROUP PN AND 3 SCREWS IN GROUP P THAT WERE GRADE 1; 4 SCREWS IN GROUP ON, 2 SCREWS IN GROUP O, 1 SCREW IN GROUP PN, AND 1 SCREW IN GROUP P WERE GRADE 2; 1 SCREW IN GROUP ON, 2 SCREWS IN GROUP O AND 2 SCREWS IN GROUP PN WERE GRADE 3. 1 SCREW IN GROUP ON, 8 SCREWS IN GROUP PN AND 7 SCREWS IN GROUP P WERE MEDIAL AXIAL/ CORONAL; 5 SCREWS IN GROUP PN AND 3 SCREWS IN GROUP P WERE GRADE 1; 2 SCREWS IN GROUP PN AND 8 SCREWS IN GROUP P WERE GRADE 2. 4 SCREWS IN GROUP ON, 11 SCREWS IN GROUP O, 8 SCREWS IN GROUP PN AND 10 SCREWS IN GROUP P WERE ANTERIOR AXIAL; 1 SCREW IN GROUP O AND 4 SCREWS IN GROUP P WERE GRADE 1; 2 SCREWS IN GROUP O AND 6 SCREWS IN GROUP P WERE GRADE 2. 5 SCREWS IN GROUP ON AND 2 SCREWS IN GROUP P WERE CAUDAL SAGITTAL/ CORONAL; 1 SCREW IN GROUP P WAS GRADE 1. 1 SCREW IN GROUP ON AND 1 SCREW IN GROUP P WERE CRANIAL SAGITTAL/ CORONAL. 1 PATIENT IN GROUP ON AND 1 PATIENT IN GROUP O HAD TRANSIENT NEUROLOGICAL DEFICIT. 2 PATIENTS IN GROUP O HAD SUPERFICIAL WOUND INFECTION TREATED WITH DEBRIDEMENT AND ANTIBIOTICS. 2 PATIENTS IN GROUP ON HAD SUPERFICIAL WOUND INFECTION TREATED WITH ANTIBIOTICS. 1 PATIENT IN GROUP ON HAD DEEP WOUND INFECTION. 1 PATIENT IN GROUP ON, 2 PATIENTS IN GROUP O AND 1 PATIENT IN GROUP P HAD PROLONGATION OF STABILIZATION. PATIENTS WHO UNDERWENT REPLACEMENT OF IMPLANT BECAUSE OF PAIN WERE: 1 PATIENT IN GROUP PN WHO HAD L4 MEDIAL DISPLACEMENT GRADE 3 AFTER 1 WEEK. 1 PATIENT IN GROUP P WHO HAD INTRAOPERATIVE D12 MEDIAL DISPLACEMENT GRADE 3. 1 PATIENT IN GROUP P WHO HAD L5 MEDIAL DISPLACEMENT GRADE 3 AFTER 1 WEEK. 1 PATIENT IN GROUP P WHO HAD L5 MEDIAL DISPLACEMENT GRADE 3 AFTER 2 MONTHS. 2 PATIENTS IN GROUP P WHO HAD L5 MEDIAL DISPLACEMENT GRADE 3 AND L4 MEDIAL DISPLACEMENT GRADE 3 AFTER 2 DAYS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE VIPER 2 AND UNKNOWN DEPUY SPINE EXPEDIUM. IT CAPTURES THE REPORTED SCREW BREACHES IN LUMBAR VERTEBRAE (IT IS UNKNOWN WHICH OF THE VIPER 2 AND EXPEDIUM WERE USED). THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4). THE COMPLAINT INVOLVES TOTAL 126 DEVICES. ADDITIONAL DEVICES ARE REPORTED UNDER COMPLAINTS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116 UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention