BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 9553074 · Received January 6, 2020

    Report

    Report Number
    1526439-2020-00145
    Event Type
    Injury
    Date Received
    January 6, 2020
    Report Date
    December 10, 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

    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. PRODUCT WAS NOT RETURNED. 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: LI M., ET AL (2009): "CORONAL AND SAGITTAL PLANE CORRECTION IN PATIENTS WITH LENKE 1 ADOLESCENT IDIOPATHIC SCOLIOSIS A COMPARISON OF CONSECUTIVE VERSUS INTERVAL PEDICLE SCREW PLACEMENT", JOURNAL OF SPINAL DISORDERS AND TECHNIQUES, VOLUME 22, NUMBER 4, PAGES 251-256(CHINA). THIS STUDY AIMS TO PRESENT THE RADIOGRAPHIC AND CLINICAL OUTCOMES OF A RANDOMIZED PROSPECTIVE STUDY COMPARING POSTERIOR CONSECUTIVE PEDICLE SCREW VERSUS INTERVAL PEDICLE SCREW INSTRUMENTATION FOR THE TREATMENT OF LENKE 1 AIS. BETWEEN JUNE 2003 AND DECEMBER 2005, 30 PATIENTS DIAGNOSED AS HAVING LENKE 1 IDIOPATHIC SCOLIOSIS WERE ENROLLED IN THIS PROSPECTIVE CLINICAL STUDY. THE PATIENTS WERE RANDOMIZED INTO 1 OF 2 GROUPS ACCORDING TO THE ORDER OF HOSPITALIZATION. PATIENTS ADMITTED ON AN ODD NUMBER WERE ENROLLED IN 1 GROUP (CONSECUTIVE PEDICLE SCREW GROUP), WHEREAS PATIENTS ADMITTED ON AN EVEN NUMBER WERE ENROLLED IN THE OTHER GROUP (INTERVAL PEDICLE SCREW GROUP). THE CONSECUTIVE PEDICLE SCREW GROUP INCLUDED THE FOLLOWING IMPLANT CASES: 3 ISOLA (DEPUY SPINE INC, RAYNHAM, MA), AND 8 MOSS-MIAMI (DEPUY SPINE INC). THE INTERVAL PEDICLE SCREW GROUP INCLUDED THE FOLLOWING IMPLANT CASES: 9 MOSS-MIAMI (DEPUY SPINE INC). ALL SCREWS WERE MONO-AXIAL. THE MEAN FOLLOW-UP PERIOD WAS 2.3 YEARS (RANGE, 2 TO 4.1 Y). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: INTERVAL PEDICLE SCREW GROUP: PSEUDARTHROSIS WITH INSTRUMENTATION FAILURE OCCURRED IN 1 CASE IN THE INTERVAL PEDICLE SCREW GROUP. THIS WAS TREATED BY FURTHER SURGERY, DURING WHICH THE MOSS-MIAMI INSTRUMENTATION WAS REMOVED AND POSTERIOR INSTRUMENTED FUSION WITH NEW MOSS-MIAMI INSTRUMENTATION PERFORMED. THE PSEUDARTHROSIS DEFECT WAS FILLED WITH A LARGE AMOUNT OF AUTOLOGOUS CANCELLOUS BONE CHIP. AT THE LAST FOLLOW-UP (1.5 Y AFTER THE REVISION SURGERY), THERE WAS NO EVIDENCE OF INSTRUMENTATION FAILURE. THERE WAS A SINGLE CASE OF POSTOPERATIVE SUPERFICIAL WOUND INFECTION IN THE INTERVAL PEDICLE SCREW GROUP. THIS PATIENT FULLY RECOVERED WITH CONSERVATIVE TREATMENT. CONSECUTIVE PEDICLE SCREW GROUP: TWO CASES OF DEEP WOUND INFECTION OCCURRED IN THE CONSECUTIVE PEDICLE SCREW GROUP, 3 WEEKS AND 3 MONTHS AFTER SURGERY. THESE PATIENTS WERE TREATED SURGICALLY WITH IRRIGATION AND DEBRIDEMENT AND RECEIVED POSTOPERATIVE INTRAVENOUS ANTIBIOTICS. INSTRUMENTATION WAS REMOVED IN ONE OF THESE PATIENTS AND RETAINED IN THE OTHER. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE MOSS MIAMI AND ISOLA. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16024 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention