BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORTHOSIS,PEDICLE SPINAL FIXATION

    MDR report key: 8457715 · Received March 27, 2019

    Report

    Report Number
    8030965-2019-62285
    Event Type
    Death
    Date Received
    March 27, 2019
    Report Date
    March 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNI
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THE INITIAL MW WAS SUBMITTED IN ERROR. THIS EVENT WAS INITIALLY REPORTABLE FOR THE ONE PATIENT THAT DIED (SEPSIS AND MODS), HOWEVER AFTER FURTHER REVIEW BY MEDICAL SAFETY OFFICER, IT WAS DETERMINED THAT THE DEATH IS NOT ASSOCIATED WITH THE SYNTHES IMPLANTS AND IS NOT REPORTABLE. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN USS CONSTRUCT. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN USS CONSTRUCT. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RICHARD A. LINDTNER ET AL. (2017), FRACTURE REDUCTION BY POSTOPERATIVE MOBILIZATION FOR THE TREATMENT OF HYPEREXTENSION INJURIES OF THE THORACOLUMBAR SPINE IN PATIENTS WITH ANKYLOSING SPINAL DISORDERS, ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, VOL. 137(4), PAGES 531-541 (AUSTRIA). THE AIM OF THIS STUDY WAS TO EVALUATE CLINICAL AND RADIOLOGICAL OUTCOME AFTER SURGICAL STABILIZATION OF HYPEREXTENSION INJURIES OF THE THORACOLUMBAR SPINE IN PATIENTS WITH ANKYLOSING SPINAL DISORDERS USING TWO DIFFERENT TREATMENT STRATEGIES: THE CONVENTIONAL OPEN RIGID POSTERIOR INSTRUMENTATION AS WELL AS A NEW TREATMENT CONCEPT INVOLVING PERCUTANEOUS LESS RIGID POSTERIOR INSTRUMENTATION AND FRACTURE REDUCTION BY POSTOPERATIVE MOBILIZATION. BETWEEN JANUARY 2006 AND JUNE 2012, A CONSECUTIVE SERIES OF 20 PATIENTS WERE INCLUDED IN THE STUDY WHICH THERE WERE 14 PATIENTS IN THE OPEN RIGID (OR) AND 6 PATIENTS IN THE PERCUTANEOUS LESS RIGID (PLR) GROUP (18 MALE AND 2 FEMALE) WITH A MEAN AGE AT TIME OF SURGERY WAS 74.7 YEARS WERE INCLUDED IN THE STUDY. THE UNIVERSAL SPINE SYSTEM (USS) LOW PROFILE PEDICLE SCREW SYSTEM WAS INSERTED VIA A STANDARD OPEN POSTERIOR MIDLINE APPROACH. THE FINAL CLINICAL FOLLOW-UP EXAMINATION WAS PERFORMED AFTER A MEAN OF 29.2 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 CASES HAD PEDICLE SCREW LOOSENING. 3 CASES EXPERIENCE IMPAIRED WOUND HEALING WHICH REQUIRED REVISION SURGERY IN 2 PATIENTS. 10 PATIENTS HAD POSTOPERATIVE PULMONARY COMPLICATIONS. 1 PATIENT FROM THE OR GROUP DIED ON DAY 13 AFTER SURGERY DUE TO SEPSIS AND MULTIPLE ORGAN DYSFUNCTION SYNDROMES (MODS). 4 PATIENTS HAD URINARY TRACT INFECTION. 1 PATIENT HAD DELIRIUM. 1 PATIENT HAD DECUBITAL ULCERA. 2 PATIENTS HAD SEPSIS. THIS REPORT IS FOR A UNIVERSAL SPINE SYSTEM (USS) LOW PROFILE PEDICLE SCREW SYSTEM. IT CAPTURES 1 PATIENT FROM THE OR GROUP DIED ON DAY 13 AFTER SURGERY DUE TO SEPSIS AND MULTIPLE ORGAN DYSFUNCTION SYNDROME. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251160 ORTHOSIS,PEDICLE SPINAL FIXATION MNI OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death