BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREW/ROD CONSTRUCT ACCESSORIES: EXPEDIUM

    MDR report key: 12435028 · Received September 7, 2021

    Report

    Report Number
    1526439-2021-01847
    Event Type
    Injury
    Date Received
    September 7, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 AUGUST 2007 AND MAY 2010. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LERNER T., LILJENQVIST U., ET AL (2013) : SILICATE-SUBSTITUTED CALCIUM PHOSPHATE AS A BONE GRAFT SUBSTITUTE IN SURGERY FOR ADOLESCENT IDIOPATHIC SCOLIOSIS , EUR SPINE J VOLUME 22 (SUPPL 2):PAGES S185¿S194 (GERMANY). THIS PROSPECTIVE STUDY AIMS TO EVALUATE THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF THE USE OF SI-CAP AS A BONE GRAFT SUBSTITUTE IN POSTERIOR CORRECTION AND FUSION FOR ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS). FROM AUGUST 2007, 21 CONSECUTIVE PATIENTS (18 FEMALES, 3 MALES) WITH AN AVERAGE AGE OF 16 YEARS (MEDIAN 16 ± 2 YEARS; 12¿21 YEARS) AT DATE OF SURGERY WITH AIS WERE ENROLLED IN THIS STUDY. ALL PATIENTS UNDERWENT CORRECTIVE INSTRUMENTATION THROUGH A POSTERIOR PROCEDURE BY MEANS OF A MULTISEGMENTED TITANIUM PEDICLE SCREW AND ROD SYSTEM (EXPEDIUM SPINE SYSTEM, DEPUY SPINE INC., RAYNHAM, MASSACHUSETTS, USA). ALL OPERATIONS WERE PERFORMED BY ONE SURGEON (U.L.). FOLLOW-UP AVERAGED 25 MONTHS (24 ± 2 MONTHS; 24¿33 MONTHS). A STATISTICALLY SIGNIFICANT LOSS OF CORRECTION OF ON AVERAGE 2 WAS RECORDED AT FINAL FOLLOW-UP (P = 0.0007), WITH A MAXIMUM LOSS OF CORRECTION OF 7 (8 %) IN ONE PATIENT OBSERVED AT THE 4-MONTHS FOLLOW-UP. AFTER THE 4-MONTHS FOLLOW-UP, THERE WAS NO MORE NOTICEABLE LOSS OF CORRECTION (P = 0.9). AT DISCHARGE, 20 PATIENTS WERE ADEQUATELY SUPPLIED WITH ANALGESICS. AT FINAL FOLLOWUP, TWO PATIENTS REPORTED STILL USING AN OVER THE COUNTER ANALGESIC OCCASIONALLY BECAUSE OF PAINFUL MUSCULAR TENSION. REVISION SURGERY FOR A DISLOCATED SET SCREW AT THE DISTAL END OF INSTRUMENTATION, 1 YEAR AFTER POSTERIOR CORRECTIVE SURGERY FOR SCHEUERMANN KYPHOSIS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE TITANIUM PEDICLE SCREW AND ROD SYSTEM (EXPEDIUM SPINE SYSTEM). THIS REPORT IS FOR ONE (1) 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
    1332409 UNK - SCREW/ROD CONSTRUCT ACCESSORIES: EXPEDIUM ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention