BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CAGE/SPACER

    MDR report key: 11845699 · Received May 18, 2021

    Report

    Report Number
    1526439-2021-00983
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    March 8, 2016
    Report Date
    April 20, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CAGE/SPACER/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MARUENDA JI, ET AL (2016), ADJACENT SEGMENT DEGENERATION AND REVISION SURGERY AFTER CIRCUMFERENTIAL LUMBAR FUSION: OUTCOMES THROUGHOUT 15 YEARS OF FOLLOW-UP, EUR SPINE J, VOLUME 25, PAGE 1550-1557, (SPAIN). THIS RETROSPECTIVE STUDY ANALYZES LONG-TERM OUTCOMES (15 YEARS) OF CIRCUMFERENTIAL LUMBAR FUSION (CF) FOR DEGENERATIVE SPINE DISEASE USING INSTRUMENTED PLIF. THE OCCURRENCE OF ADJACENT SEGMENT DEGENERATION (ASD) AND THE REINTERVENTION RATE WAS SPECIALLY FOCUSED. FROM FEBRUARY 1998 TO JUNE 2000, 73 PATIENTS WHO UNDERWENT CIRCUMFERENTIAL LUMBAR FUSION BECAUSE OF DEGENERATIVE LUMBAR SPINE DISEASE WERE INCLUDED IN THE STUDY. THERE WERE 42 FEMALES AND 31 MALES WITH A MEAN AGE OF 49 YEARS (RANGE, 21-68 YEARS). ALL PATIENTS UNDERWENT CF COMBINING INSTRUMENTED PLIF USING TWO CAGES WITH POSTERIOR TRANSPEDICULAR SCREW FIXATION INVOLVING ONE THREE LEVELS. A COMPETITOR¿S PEDICLE INSTRUMENTATION SYSTEM WAS USED. IN 68 PATIENTS, AN UNKNOWN DEPUY SPINE BRANTIGAN CAGE WAS USED WHILE IN 5 PATIENTS, A COMPETITOR¿S CAGE WAS USED. FOLLOW-UP EXAMINATIONS WERE PERFORMED AT 3, 6 MONTHS, 1 AND 2 YEARS AFTER THE SURGERY. PAST THAT TIME, PATIENTS WERE EVALUATED AT DEMAND. ALL PATIENTS PASSED A NEW CLINICAL AND RADIOGRAPHIC ASSESSMENT 10 AND 15 YEARS AFTER SURGERY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD A DURAL TEAR THAT WAS SUTURED DURING SURGERY. 7 PATIENTS HAD TRANSIENT IRRITATION RADICULOPATHY AT THE IMMEDIATE POSTOPERATIVE PERIOD. 3 PATIENTS DEVELOPED SEROMA AT THE IMMEDIATE POSTOPERATIVE PERIOD. 2 PATIENTS HAD POSTOPERATIVE DEEP HEMATOMA AT THE IMMEDIATE POSTOPERATIVE PERIOD. 51 PATIENTS HAD AN ADJACENT SEGMENT DEGENERATION DURING THE ENTIRE FOLLOW-UP AND 24 HAD NEW SURGICAL PROCEDURE. 7 PATIENTS HAD REVISION SURGERY AT 5-YEAR FOLLOW-UP. 18 PATIENTS HAD REVISION SURGERY AT 10-YEAR FOLLOW-UP. 24 PATIENTS HAD REVISION SURGERY AT 15-YEAR FOLLOW-UP. THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE BRANTIGAN CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740234 UNKNOWN CAGE/SPACER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR OVD MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention