BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 9491526 · Received December 18, 2019

    Report

    Report Number
    1526439-2019-52716
    Event Type
    Injury
    Date Received
    December 18, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN 2003 TO 2006. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). SURGICAL INTERVENTION IN THE FORM OF REVISION SURGERY.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FENGHUA, T. ET AL. (2011), DETERMINATION OF LOWEST INSTRUMENTED VERTEBRA BY THE LOCATION OF APICAL VERTEBRA IN LENKE TYPE 1 ADOLESCENT IDIOPATHIC SCOLIOSIS, INTERNATIONAL ORTHOPAEDICS (SICOT), VOL. 35, PAGES 561-567 (CHINA). THE AIM OF THIS PROSPECTIVE CASE-MATCHED STUDY WAS TO COMPARE THE OUTCOMES OF USING THE NEUTRAL VERTEBRA VERSUS THE APICAL VERTEBRA TO DETERMINE THE LIV IN PATIENTS WITH AIS UNDERWENT POSTERIOR SPINAL FUSION. FROM 2003 TO 2006, A TOTAL OF 72 PATIENTS WITH AN AVERAGE AGE OF 13.6 YEARS (RANGE: 11.2¿16.3 YEARS) UNDERWENT POSTERIOR FIXATION USING A MOSS MIAMI (DEPUY SPINE, INC., RAYNHAM, MA, USA) AND AN ISOLA (DEPUY SPINE, INC., RAYNHAM, MA, USA). THE AVERAGE FOLLOW-UP TIME WAS MORE THAN 3 YEARS (RANGE: 2.1¿4.6 YEARS). THE PATIENTS WERE DIVIDED INTO 2 GROUPS, AN APICAL VERTEBRA METHOD GROUP (GROUP A) AND A NEUTRAL VERTEBRA METHOD GROUP (GROUP B), WITH 36 PATIENTS IN EACH GROUP. THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: GROUP A 2 PATIENTS HAD MORE THAN 2CM OF PLUMB LINE DEVIATION FROM THE CSVL. 2 PATIENTS WHICH THE APICAL VERTEBRA WAS AT T6¿T6/7, T11 WAS SELECTED AS THE LIV AND THE AVERAGE CORRECTION RATE WAS 62 PERCENT. 15 PATIENTS IN WHICH THE APICAL VERTEBRA WAS AT T7¿T8, T12 WAS SELECTED AS THE LIV AND THE AVERAGE CORRECTION RATE WAS 71 PERCENT BUT IMBALANCE OCCURED IN 1 PATIENT. 19 PATIENTS IN WHICH THE APICAL VERTEBRA WAS AT T8/ 9¿T10, L1 WAS SELECTED AS THE LIV AND THE AVERAGE CORRECTION RATE WAS 75 PERCENT BUT IMBALANCE OCCURED IN 1 PATIENT. GROUP B 5 PATIENTS HAD MORE THAN 2CM OF PLUMB LINE DEVIATION FROM THE CSVL. 2 PATIENTS IN WHICH THE APICAL VERTEBRA WAS AT T6¿T6/7, T11 WAS SELECTED AS THE LIV AND THE AVERAGE CORRECTION RATE WAS 70 PERCENT. 15 PATIENTS IN WHICH THE APICAL VERTEBRA WAS AT T7¿T8, T11 WAS SELECTED AS THE LIV FOR ONE PATIENT, T12 FOR NINE PATIENTS, L1 FOR TWO PATIENTS AND L2 FOR THREE PATIENTS. THE AVERAGE CORRECTION RATE FOR THESE 15 PATIENTS WAS 72 PERCENT AND IMBALANCE OCCURRED IN 2 PATIENTS. 19 PATIENTS IN WHICH THE APICAL VERTEBRA WAS T8/9¿T10, T12 WAS SELECTED AS THE LIV FOR ONE PATIENT, L1 FOR 16 PATIENTS AND L2 FOR ONE PATIENT. THE AVERAGE CORRECTION RATE IN THESE 19 PATIENTS WAS 73 PERCENT AND IMBALANCE OCCURRED IN 3 PATIENTS. 2 PATIENTS HAD SHOULDER HEIGHT ASYMMETRY. THIS IS FOR A MOSS MIAMI (DEPUY SPINE, INC., RAYNHAM, MA, USA) AND AN ISOLA (DEPUY SPINE, INC., RAYNHAM, MA, USA). THIS REPORT IS FOR ONE UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283558 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention