BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 12382627 · Received August 30, 2021

    Report

    Report Number
    1030489-2021-01099
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Date of Event
    December 3, 2018
    Report Date
    August 30, 2021
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    HWC
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. AS PER THE MEDICAL SAFETY ASSESSMENT, THE REPORTED EVENTS AS LABELED COMPLICATIONS PER IFU (M708348B093E REV. F) AND/OR ARE PREDICTED IN THIS PATIENT POPULATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ORI BARZILAI, MD, LILY MCLAUGHLIN, BS, ERIC LIS, MD, ANNE S. REINER, MPH, MARK H. BILSKY, MD, ILYA LAUFER, MD. UTILITY OF CEMENT AUGMENTATION VIA PERCUTANEOUS FENESTRATED PEDICLE SCREWS FOR STABILIZATION OF CANCER-RELATED SPINAL INSTABILITY. OPERATIVE NEUROSURGERY 16:593¿599, 2019. DOI: 10.1093/ONS/OPY186. SUMMARY: CANCER PATIENTS EXPERIENCE PATHOLOGICAL FRACTURES AND THE TYPICAL POOR BONE QUALITY FREQUENTLY COMPLICATES STABILIZATION. METHODS FOR OVERCOMING SCREW FAILURE INCLUDE UTILIZATION OF FENESTRATED SCREWS THAT PERMIT THE INJECTION OF BONE CEMENT INTO THE VERTEBRAL BODY TO AUGMENT FIXATION. BONE QUALITY IS TYPICALLY POOR IN CANCER PATIENTS DUE TO THE OSTEOLYTIC METASTASES, CHEMOTHERAPY, RADIATION, AND OTHER COMORBIDITIES. THIS IS A RETROSPECTIVE CHART AND IMAGING REVIEW AT A TERTIARY CANCER CENTER BETWEEN APRIL 2016 AND AUGUST 2017. PATIENTS WITH NEOPLASTIC SPINAL INSTABILITY WHO UNDERWENT PERCUTANEOUS INSTRUMENTED SPINAL STABILIZATION WITH CEMENT AUGMENTATION USING FENESTRATED PEDICLE SCREWS (MEDTRONIC, DUBLIN, IRELAND) AND WERE FOLLOWED UP CLINICALLY, RADIOLOGICALLY OR BOTH AT LEAST 6 WK POSTOPERATIVELY AT TIME OF DATA COLLECTION WERE INCLUDED. AFTER VERIFICATION OF PROPER SCREW POSITIONING, PMMA WAS INJECTED BILATERALLY AT EACH LEVEL THROUGH THE FENESTRATED SCREWS UNDER FLUOROSCOPIC GUIDANCE. IN CASES WHERE CEMENT EXTRAVASATION IS SUSPECTED, AS SUGGESTED BY FLUOROSCOPY, INJECTION OF CEMENT IS STOPPED. FIFTY-THREE PATIENTS WERE INCLUDED IN THE ANALYSIS (30 MALE, 57%). MEDIAN AGE AT THE TIME OF SURGERY WAS 63.5 YR. THE MOST COMMON PATHOLOGIES WERE LUNG AND RENAL CELL CARCINOMA WITH A SIMILAR DISTRIBUTION AMONG SPINE SEGMENTS ACROSS THE STUDY COHORT WITH 38% THORACIC, 36% LUMBAR, AND 26% IN THE THORACOLUMBAR REGION. THE DATA PRESENTED DEMONSTRATE THAT WHEN PROPERLY PLACED, THE RISKS OF HARDWARE FAILURE INCLUDING SCREW PULL OUT, INSTRUMENTATION BREAKAGE, OR LUCENCY ARE LOW. THE USE OF FENESTRATED SCREWS FACILITATES THIS PROCESS WITH LOW MORBIDITY AND SHORT OPERATIVE TIMES. EVENT: ONE PATIENT HAD AN ASYMPTOMATIC SCREW FRACTURE AT 6 MO POSTOPERATIVELY THAT DID NOT REQUIRE INTERVENTION. INTRAOPERATIVE SUSPICION OF CEMENT EXTRAVASATION EITHER ANTERIORLY TO A DRAINING BLOOD VESSEL OR POSTERIORLY TOWARDS THE SPINAL CANAL WAS SUSPECTED IN 17 CASES PROMPTING CESSATION OF CEMENT INJECTION, OF WHICH 1 PATIENT HAD EVIDENCE OF CEMENT EMBOLUS IN THE PULMONARY ARTERY. THIS RADIOLOGICAL FINDING DID NOT REQUIRE INTERVENTION AS AT THE TIME THE PATIENT REMAINED ASYMPTOMATIC. THREE PATIENTS REQUIRED A REOPERATION. ONE PATIENT PRESENTED AT 3-MO FOLLOW-UP WITH RECURRENCE OF MECHANICAL BACK PAIN. RADIOGRAPHIC EVIDENCE DEMONSTRATED PULL OUT OF THE BOTTOM SCREWS OF HER CONSTRUCT. INTERESTINGLY, INTRAOPERATIVE IMAGES DEMONSTRATED A PAUCITY OF CEMENT INJECTED INTO THESE SCREWS AS THERE WAS SUSPICION OF CEMENT EXTRAVASATION PROMPTING CESSATION OF CEMENT INJECTION DURING THE INITIAL SURGERY. SHE WAS SUBSEQUENTLY TAKEN FOR HARDWARE REVISION. ANOTHER PATIENT REQUIRED REVISION OF INSTRUMENTATION SECONDARY TO A FRACTURE OF AN INSTRUMENTED PEDICLE 1 MO AFTER THE INITIAL SURGERY. ONE PATIENT REQUIRED A WOUND REVISION DUE TO DEHISCENCE WHILE RECEIVING BEVACIZUMAB SYSTEMIC COMPLICATIONS INCLUDED A PULMONARY CEMENT EMBOLISM, A LOWER EXTREMITY DEEP VEIN THROMBOSIS, AND A POSTOPERATIVE MORTALITY SECONDARY TO PULMONARY FAILURE FROM WIDESPREAD METASTATIC PULMONARY INFILTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286290 UNKNOWN HWC MDT SOFAMOR DANEK PUERTO RICO MFG MSB_UNK_SCREW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1