BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, PEDICLE SPINAL FIXATION

    MDR report key: 8571144 · Received May 1, 2019

    Report

    Report Number
    8030965-2019-63361
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    August 13, 2009
    Report Date
    April 4, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES MONO/POLYAXIAL SCREWS: UNIVERSAL SPINAL SYSTEM (USS)/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. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: STECHOW, D ET AL (2009), EFFECTIVENESS OF COMBINATION USE OF ANTIBIOTIC-LOADED PEROSSAL _ WITH SPINAL SURGERY IN PATIENTS WITH SPONDYLODISCITIS , EUROPEAN SURGICAL RESEARCH 2009 (43)298-305 (GERMANY) DOI: 10.1159/000233525. THIS CLINICAL STUDY AIMS TO INVESTIGATE WHETHER A DEGRADABLE CARRIER (PEROSSAL) LOADED WITH VARIABLE ANTIBIOTICS IS EFFECTIVE IN THE TREATMENT OF PATIENTS WITH SPONDYLODISCITIS AND IS EASY TO HANDLE. A TOTAL OF 12 PATIENTS (8 MALE AND 4 FEMALE) RANGING FROM 39 TO 74 YEARS OLD WITH THE MEAN AGE OF 59 YEARS (RANGE, 39¿74 YEARS) WITH ACUTE OR CHRONIC SPONDYLODISCITIS WHO UNDERWENT DORSAL SURGICAL APPROACH FOLLOWED BY DORSAL INSTRUMENTATION HAD BEEN ENROLLED IN THIS STUDY. UNIVERSAL SPINE SYSTEM _ (SYNTHES, UMKIRCH, GERMANY; N = 3) WAS USED FOR INSTRUMENTATION. THE MEAN FOLLOW-UP WAS A PERIOD OF AT LEAST 12 MONTHS AFTER SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) MALE UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE SCREW. A (B)(6) MALE HAD DEEP VENOUS THROMBOSIS. A (B)(6) FEMALE HAD A REVISION SURGERY DUE TO LOOSENING OF THE SCREW AND PSEUDARTHROSIS. A (B)(6) MALE UNDERWENT REVISION SURGERY DUE TO SCREW FAILURE. THIS REPORT IS FOR A (B)(6) FEMALE WHO HAD LOOSENING SCREW AND PSEUDOARTHROSIS REQUIRING REVISION SURGERY. THIS REPORT IS FOR AN UNKNOWN SYNTHES MONO/POLYAXIAL SCREWS: UNIVERSAL SPINAL SYSTEM (USS). THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363009 ORTHOSIS, PEDICLE SPINAL FIXATION MNI OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention