BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRS® ROTARY MIXER CEMENT 10CC STERILE

    MDR report key: 3590911 · Received January 24, 2014

    Report

    Report Number
    1719045-2014-00046
    Event Type
    Death
    Date Received
    January 24, 2014
    Date of Event
    August 17, 2007
    Report Date
    January 6, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GXP
    PMA / PMN Number
    K973789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. MFR DATE: 9/25/2006 AND 11/17/2006. NORIAN CORPORATION (PRESENTLY DSM BIOMEDICAL) MANUFACTURED THE CRS ROTARY MIXER CEMENT 10CC - STERILE, SYNTHES P/N 614.10.01S (NORIAN P/N CRS-010-RMS). THE LOT CONFORMED TO NORIAN WORK ORDER 7666 WN (CLOSED 9/19/06) AND SYNTHES PURCHASE ORDERS 674203 AND 701027. THERE WERE NO MRRS, NCRS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. THE TWO RECEIPTS OF THIS LOT WERE RELEASED 9/25/2006 AND 11/7/2006 RESPECTIVELY. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT HAD A FALL IN HONDURAS FROM THE SECOND FLOOR ON (B)(6) 2007. THAT IS WHAT LED TO THE DISCOVERY OF HER PULMONARY MASS. SHE HAS A FRACTURE OF L1 WITH BONE FRAGMENTS INSIDE OF THE CANAL AS WELL AS FRACTURE/ABNORMALITIES ON L4 AND T10. BETWEEN 1992 AND 1993, THE PATIENT APPARENTLY WAS VERY ILL AND ENDED UP HAVING A DIAGNOSIS OF FIBROMYALGIA. MEDICAL DOCTOR REVIEWED THE PATIENTS MOST RECENT X-RAYS, INCLUDING AN MRI OF HER SPINE AND A PET SCAN. THE PET SCAN SUGGESTED THAT SHE HAS A LOCALIZED, NON-SMALL CELL LUNG CANCER. THE RIGHT UPPER LOBE LUNG MASS HAD A MAXIMUM SUV OF 13.2. THERE WAS A RIGHT PARATRACHEAL MEDIASTINAL NODE WHICH WAS ALSO HYPERMETABOLIC WITH AN SUV OF 4.5. THE MRI SUGGESTED THE LESION AT T10 COULD REPRESENT METASTASIS. MRI OF HER SPINE SHOWED THE PRESENCE OF MULTIPLE COMPRESSION FRACTURES. IT DID NOT DESCRIBE ANY CLEAR INVOLVEMENT BY TUMOR OR SUSPICION OF THAT AND BELIEVED THERE WAS A COMPONENT OF OSTEOPOROSIS PLUS THE TRAUMA FROM THE FALL. PATIENT DID HIT HER HEAD WITHOUT LOSING CONSCIOUSNESS; SHE HAD A HEAD CT THAT WAS UNREMARKABLE FOR THE PRESENCE OF A SUBDURAL HEMATOMA NOR ANY EVIDENCE OF FRACTURE. THE PATIENT PRESENTS WITH A LUNG MASS THAT SEEMS TO HAVE BEEN FINDING BASED ON THE HISTORY OF TRAUMA TO THE SPINE. THERE IS NO CLEAR EVIDENCE THAT THERE IS INVOLVEMENT OF HER SPINE BY POSSIBLE METASTATIC LUNG CANCER. THE REPORTS FOR HONDURAS DO NOT DESCRIBE ANY IMPINGEMENT ON THE SPINAL CORD BY THE BONE FRACTURES.

    Description of Event or Problem · 1

    AUTOPSY REPORT REPORTED THE FOLLOWING: PATHOLOGICAL DIAGNOSIS: FAT EMBOLISM SYNDROME. A. INTRA-OPERATIVE DEATH DURING ORTHOPEDIC SURGERY ON THORACOLUMBAR SPINE. B. FRACTURES OF LOWER SPINE DUE TO BLUNT FORCE INJURY. C. ORTHOPEDIC STABILIZATION HARDWARE FASTENED INTO THORACOLUMBAR SPINE. D. RETROPERITONEAL HEMORRHAGE, BILATERAL, PREDOMINANTLY RIGHT SIDE. E. BONE, BONE MARROW AND FAT EMBOLI IN PULMONARY BLOOD VESSELS. CARCINOMA OF LUNG, NON-SMALL CELL TYPE, RIGHT UPPER LOBE. PULMONARY EMPHYSEMA. OSTEOPENIA. ATHEROSCLEROTIC CARDIOVASCULAR DISEASE WITH MILD CORONARY ATHEROSCLEROSIS. EVIDENCE OF MEDICAL AND SURGICAL THERAPY. CHIEF MEDICAL EXAMINER NOTED THE CAUSE OF DEATH OF THIS (B)(6) WOMAN WHO DIED INTRA-OPERATIVELY IS FAT EMBOLISM SYNDROME DUE TO ORTHOPEDIC SURGERY FOR THERAPY OF THORACOLUMBAR SPINE FRACTURES DUE TO BLUNT FORCE INJURY OF THE SPINE RESULTING FROM A FALL. A CONTRIBUTION TO THE EMBOLISM SYNDROME DUE TO THE BONE CEMENT CANNOT BE EXCLUDED. THE MANNER OF DEATH IS ACCIDENT.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT INDICATES A FEMALE EXPERIENCED INTRAOPERATIVE DEATH DUE TO SEVERE PULMONARY EMBOLISM (PE)(CEMENT AND FAT) DURING MAJOR SPINE SURGERY INCLUDING CORPECTOMIES, LAMINECTOMIES, FUSION AND VERTEBROPLASTIES. THE PATIENT ALSO DEVELOPED INTRAOPERATIVE DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC). PE WAS RECOGNIZED MINUTES AFTER NORIAN TM WAS INJECTED INTO THE VERTEBRAL BODIES. DIC DEVELOPED APPROX. 30-45 MINUTES AFTER PE. AFTER THESE EVENTS, THE PATIENT WAS TREATED WITH PRESSORS, MECHANICAL VENTILATION AND MASSIVE TRANSFUSION BUT DEVELOPED CARDIOPULMONARY COLLAPSE WITHOUT RESPONSE TO APPROPRIATE RESUSCITATIVE EFFORTS. AN AUTOPSY WAS PERFORMED FINDING FAT AND CEMENT FRAGMENTS IN THE PULMONARY VASCULATURE. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57115 CRS® ROTARY MIXER CEMENT 10CC STERILE GXP SYNTHES MONUMENT N765402

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death