BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH

    MDR report key: 11631667 · Received April 7, 2021

    Report

    Report Number
    1526439-2021-00654
    Event Type
    Injury
    Date Received
    April 7, 2021
    Report Date
    March 11, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SURGICAL TITANIUM MESH/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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: BASANKIN I, ET AL. (2016), THE INFLUENCE OF THE FUSION DEGREE OF THE VERTEBRAE ON THE PROCESS OF DESTABILIZATION OF THE PEDICLE FIXATION SYSTEM AFTER TLIF AND PLIF, GLOBAL SPINE JOURNAL, DOI: 10.1055/S-0036-1583102, (RUSSIA). SINCE DECEMBER 25, 2012 TILL DECEMBER 27, 2013, 409 WHO UNDERWENT DECOMPRESSIVE-STABILIZING OPERATIONS ON THE LUMBAR SPINE TYPE TLIF OR PLIF BECAUSE OF SPIRAL STENOSIS WERE INCLUDED IN THE STUDY. THERE WERE 235 MALES AND 174 FEMALES AGED 18¿75 YEARS. THERE WAS A TOTAL OF 539 SEGMENTS OPERATED. THE CAGES USED FOR INTERBODY IMPLANTS WERE UNKNOWN DEPUY LEOPARD CAGE IN 65 SEGMENTS, UNKNOWN DEPUY CONCORDE CAGE IN 92 SEGMENTS, UNKNOWN DEPUY SURGICAL TITANIUM MESH IN 226 SEGMENTS, AND A COMPETITOR¿S CAGE IN 156 SEGMENTS. THE CAGES WERE FILLED WITH AUTOLOGOUS BONE GRAFT. CRUSHED BONE STACKED DENSELY AROUND THECAGE. AFTER INSTALLATION OF THE CAGED COMPRESSION ON THE ELEMENTS OF PEDICLE FIXATION SYSTEMW AS PERFORMED. FOLLOW-UP PERIOD WAS OF 2 YEARS. FORMATION OF THE BONE BLOCK WAS EVALUATED BY BRIDWELL CLASSIFICATION. A TOTAL OF 335 PATIENTS WERE CONTROL EXAMINED AFTER 1 YEAR AND 258 AFTER 2 YEARS. THE AUTHORS DID NOT SPECIFY WHICH PATIENTS RECEIVED THE DEPUY SPINE DEVICES. THUS, COMPLICATIONS WILL BE REPORTED AS FOLLOWS: 6 PATIENTS HAD DETERIORATION OF THE INITIAL NEUROLOGICAL SYMPTOMS. 23 PATIENTS HAD NON-FUSION WITH PSEUDOARTHROSIS AFTER 1 YEAR (3 AND 4 BRIDWELL GRADE OF FUSION). 8 OF WHICH WERE IMPLANTED WITH CARBON CAGES AND 8 WERE IMPLANTED WITH THE SURGICAL TITANIUM MESH. 13 PATIENTS HAD INSTABILITY AND FRACTURE OF NODE OF PEDICLE FIXATION SYSTEM FOR 2 YEARS AFTER SURGERY. THIS REPORT IS FOR THE UNKNOWN DEPUY SURGICAL TITANIUM MESH. IT CAPTURES THE REPORTED ADVERSE EVENTS OF DETERIORATION OF THE INITIAL NEUROLOGICAL SYMPTOMS, NON-FUSION WITH PSEUDOARTHROSIS AND INSTABILITY AND FRACTURE OF NODE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523810 UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention