BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATES

    MDR report key: 12093952 · Received June 30, 2021

    Report

    Report Number
    1526439-2021-01347
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    January 11, 2021
    Report Date
    June 8, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATE/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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HAAS P, ET AL. (2021), POSTEROLATERAL EPIDURAL SUPRA-C2-ROOT APPROACH (PESCA) FOR BIOPSY OF LESIONS OF THE ODONTOID PROCESS IN SAME SITTING AFTER OCCIPITOCERVICAL FIXATION AND DECOMPRESSION¿PERIOPERATIVE MANAGEMENT AND HOW TO AVOID VERTEBRAL ARTERY INJURY, NEUROSURGICAL REVIEW, PAGES 1-10, (GERMANY) . THIS STUDY AIMS TO DESCRIBE THE POSTEROLATERAL EPIDURAL SUPRA-C2-ROOT APPROACH (PESCA), WHICH MIGHT BE A GOOD ALTERNATIVE TO THE TRANSORAL, ANTEROLATERAL, AND OTHER POSTEROLATERAL APPROACHES FOR BIOPSY OF LESIONS OF THE ODONTOID PROCESS (OP). THE APPROACH WAS PRESENTED IN THE CASE OF A (B)(6) MAN WITH A 4-WEEK HISTORY OF HEADACHE AND NECK PAIN, WITH A WEIGHT LOSS OF OVER 20 KG IN 6 MONTHS. A COMPUTED TOMOGRAPHY (CT) OF THE CRANIOVERTEBRAL JUNCTION (CVJ) AND THE CERVICAL SPINE WAS DONE, WHICH REVEALED AN OSTEOLYTIC LESION OF THE ODONTOID WITH SIGNS OF INSTABILITY (DIFFERENTIAL DIAGNOSIS (DD) METASTASIS, DD RHEUMATOID ARTHRITIS, DD SPONDYLODISCITIS). MRI WAS NOT POSSIBLE DUE TO THE PRESENCE OF A PACEMAKER. BECAUSE THE PATIENT HAD SEVERE SECONDARY DISEASES, A STRATEGY MUST BE DONE TO SOLVE THESE PROBLEMS IN ONE SURGERY. AN APPROACH THROUGH MIDLINE INCISION FROM POSTEROLATERAL WHICH CAN BE DONE IN SAME SITTING DURING POSTERIOR CRANIOCERVICAL STABILIZATION WAS NECESSARY. A 3-STEP SURGERY WAS DONE. IN THE FIRST STEP, POSTERIOR STABILIZATION OF THE CVJ WAS PERFORMED THROUGH A C0 TO C4 FUSION THAT WAS DONE USING AN UNKNOWN DEPUY SPINE MOUNTAINEER OC PLATE. THE PEDICLE SCREW C2 WAS PLACED UNDER SPINAL NEURONAVIGATION AND AT THE LEVEL OF C3 AND C4, MASSA LATERALIS SCREWS WERE INSERTED. STEP 2 INVOLVED SPINAL DECOMPRESSION AND STEP 3 WAS THE BIOPSY OF THE LESION OF THE ODONTOID PROCESS THROUGH PESCA WHICH REVEALED A SPONDYLODISCITIS WITHOUT ANY SIGNS OF TUMOR OR RHEUMATOID DISEASE. DURING THE POSTOPERATIVE PERIOD, THE PATIENT RECOVERED FROM SURGERY WITHOUT ANY NEW DEFICITS, BUT STILL WITH HEAD AND NECK PAIN. A POSTOPERATIVE CT SCAN REVEALED A PROPER POSITIONING OF THE SCREWS AND SUFFICIENT DECOMPRESSION OF THE SPINAL CORD AT THE LEVEL OF THE CVJ. PATHOLOGIC EXAMINATION OF THE MASS SHOWED A CHRONIC RECURRENT SPONDYLODISCITIS WITHOUT ANY SIGNS OF TUMOR. AN EMPIRIC ANTIBIOTHERAPY WITH CLINDAMYCIN AND CEFTRIAXONE WAS STARTED. AFTER A FEW DAYS, A WOUND REVISION WAS PERFORMED DUE TO WOUND INFECTION WITH SCREW LOOSENING IN THE OCCIPITAL PLATE, AND SCREWS WITH LARGER DIAMETER WERE INSERTED. MICROBIOLOGICAL ANALYSIS OF THE PROBE AND SORE SMEARS DURING THE SECOND SURGERY REVEALED CORYNEBACTERIUM STRIATUM WITH MULTIPLE RESISTANCE (EVEN WITH RESISTANCE TO CLINDAMYCIN). WOUND INFECTION WAS CAUSED BY INSUFFICIENT EMPIRIC ANTIBIOTHERAPY DUE TO VARYING RESISTANCES OF THE VERY RARE BACTERIA (CORYNEBACTERIUM STRIATUM) WHICH WAS RESPONSIBLE FOR THE SPONDYLODISCITIS OF THE OP AND THE SECONDARY WOUND INFECTION. THE ANTIBIOTHERAPY WAS CHANGED TO VANCOMYCINE. 10 DAYS AFTER THE INITIATION OF VANCOMYCINE, THE PATIENT WAS TRANSFERRED IN A GOOD CONDITION WITH DECREASED INFECTION PARAMETERS. A CT SCAN OF THE CERVICAL SPINE REVEALED POSTINFECTIONAL CHANGES OF THE OP WITHOUT FURTHER DESTRUCTION OF THE OP, AND THERE WERE NO SIGNS OF SCREW LOOSENING. THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE MOUNTAINEER OC PLATES AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991265 UNKNOWN PLATES APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention