BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MONO/POLYAXIAL SCREWS

    MDR report key: 15580270 · Received October 11, 2022

    Report

    Report Number
    1526439-2022-01785
    Event Type
    Injury
    Date Received
    October 11, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WELSH CENTRE FOR SPINAL SURGERY & TRAUMA, UNIVERSITY HOSPITAL OF WALES, HEATH PARK, CARDIFF CF10 2FF, UNITED KINGDOM. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TEOH, K.H. ET AL (2016), DO MAGNETIC GROWING RODS HAVE LOWER COMPLICATION RATES COMPARED WITH CONVENTIONAL GROWING RODS?, THE SPINE JOURNAL, VOL.16 (XX), S40¿S44 (UNITED KINGDOM). THE AIM OF THIS RETROSPECTIVE CASE CONTROL STUDY IS TO EVALUATE THE COMPLICATIONS OF THE MCGR SYSTEM AGAINST THE CONVENTIONAL GROWING ROD (CGR) SYSTEM IN OUR CENTER. A TOTAL OF 37 PATIENTS WERE INCLUDED IN THE STUDY. AMONG THESE, 10 PATIENTS (8 MALE AND 2 FEMALE; AVERAGE AGE OF 8.7 YEARS [3-10]) WERE TREATED WITH MAGNETIC CONTROLLED GROWING RODS (MCGR) USING MAGEC SYSTEM (ELLIPSE TECHNOLOGIES INC, IRVINE, CALIFORNIA, USA) AND 27 PATIENTS (11 MALE AND 16 FEMALE; AVERAGE AGE OF 7.0 YEARS [3-9]) WITH CONVENTIONAL GROWTH RODS (CGR) USING EITHER PAEDIATRIC ISOLA OR PAEDIATRIC EXPEDIUM (DEPUY SYNTHES, JOHNSON & JOHNSON, RAYNHAM, MA, USA). THE AVERAGE FOLLOW-UP FOR MCGR AND CGR WAS 34 (12¿46) YEARS AND 88 (36¿167), RESPECTIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: CGR GROUP: 4 PATIENTS WERE CONVERTED TO MCGR, IE, TWO FOLLOWING ROD BREAKAGE AND TWO FOLLOWING DEEP INFECTION WITH REMOVAL OF METALWORK. 27 PATIENTS HAD AT LEAST ONE COMPLICATION AS FOLLOWS: 11 PATIENTS (16 EPISODES) HAD SUPERFICIAL INFECTION. 9 PATIENTS (10 EPISODES) HAD DEEP INFECTION. 9 PATIENTS (14 EPISODES) HAD METALWORK PROBLEMS REQUIRING REVISION: 2 REVISIONS FOR ROD BREAKAGE AND 12 REVISIONS FOR SCREW PULLOUT OR LOOSE SCREWS OR DISPLACED HOOK. 12 PATIENTS (18 EPISODES) WERE REQUIRED TO RETURN TO THEATER FOR UNPLANNED PROCEDURES: IRRIGATION AND DEBRIDEMENTS WHO DEVELOPED A DEEP WOUND INFECTION AND THE REST OF THE UNPLANNED RETURN TO THEATER WERE FOR METALWORK PROBLEMS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE PAEDIATRIC ISOLA OR PAEDIATRIC EXPEDIUM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631918 UNK MONO/POLYAXIAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH
    390722 UNK MONO/POLYAXIAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention