BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: USS

    MDR report key: 9988023 · Received April 22, 2020

    Report

    Report Number
    8030965-2020-03050
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    February 5, 2020
    Report Date
    April 2, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN USS CONSTRUCTS/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: ERICHSEN C., ET AL (2020) PERCUTANEOUS VERSUS OPEN POSTERIOR STABILIZATION IN AOSPINE TYPE A3 THORACOLUMBAR FRACTURES, BMC MUSCULOSKELETAL DISORDERS VOLUME 21 NUMBER 74, PAGES 1 - 10 (GERMANY) HTTPS://DOI.ORG/10.1186/S12891-020-3099-6. THIS RETROSPECTIVE COHORT STUDY AIMS TO COMPARE SURGICAL TREATMENT STRATEGIES OF TWO LEVEL-ONE TRAUMA CENTERS REGARDING CLINICAL AND RADIOLOGICAL OUTCOMES FOCUSING ON ISOLATED NON-OSTEOPOROTIC AOSPINE TYPE A3 FRACTURES OF THE THORACOLUMBAR SPINE AT LEVELS T11 TO L2. BETWEEN JANUARY 2013 AND DECEMBER 2015, A TOTAL OF 87 PATIENTS WITH TRAUMATIC INCOMPLETE BURST FRACTURES OF THE THORACOLUMBAR JUNCTION (VERTEBRAL BODIES T11 TO L2) TREATED WITH EITHER OF THE TWO TREATMENT STRATEGIES WERE INCLUDED IN THE STUDY. THESE PATIENST WERE DIVIDED INTO TWO GROUPS: MINIMALLY INVASIVE STABILIZATION GROUP AND OPEN STABILIZATION.FOURTY-THREE(43) PATIENTS (26 MALES AND 17 FEMALES) WITH MEAN AGE OF 48.4 UNDERWENT POSTERIOR OPEN STABILIZATION (OS; TRAUMA CENTER A) USING THE UNIVERSAL SPINE SYSTEM (USS¿; DEPUY SYNTHES COMPANIES, OBERDORF, SWITZERLAND) AND OTHER COMPETITORS DEVICES WHEREAS THE REMAINING 44 PATIENTS (19 MALES AND 25 FEMALES) WITH MEAN AGE OF 43.5 WERE TREATED USING DORSAL MINIMALLY INVASIVE STABILIZATION (MIS; TRAUMA CENTER B) USING COMPETITOR'S DEVICES.IN TOTAL 46 OUT OF 87 PATIENTS PARTICIPATED ON RADIOLOGICAL FOLLOW-UP AT LEAST 24 MONTHS AFTER FINAL SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: -THE MCS COMPONENT OF THE SF-36 SCORE SHOWED A SIGNIFICANT DIFFERENCE (P < 0.0001) WITH A LOWER SCORE IN THE MIS GROUP (41.9 POINTS) THAN IN THE OS GROUP (51.4 POINTS). -THE MIS GROUP SHOWED A SIGNIFICANTLY LOWER VAS SCORE THAN THE OS GROUP. -IN BOTH GROUPS THERE WAS LOSS OF REDUCTION COMPARING IMAGING POSTOPERATIVELY AND DURING FOLLOW-UP. -LOSS OF REDUCTION WAS 3.2°, IN THE OS GROUP 5.6° SHOWING A SIGNIFICANT DIFFERENCE. -ONE PATIENT SUFFERED FROM EARLY POSTOPERATIVE WOUND INFECTION AND NEEDED REVISION SURGERY. IMPLANT REMOVAL WAS NOT NECESSARY. -13 CASES OF IMPLANT REMOVAL. -IN THE OS GROUP ONE CASE WITH PEDICLE SCREW LOOSENING OCCURRED. DURING SCHEDULED ATS SURGERY THESE SCREWS WERE REPLACED BY SCREWS WITH THICKER DIAMETER. THIS REPORT IS FOR AN UNKNOWN SYNTHES UNIVERSAL SPINE SYSTEM. IT CAPTURES THE REPORTED EVENTS OF LOSS OF REDUCTION, POSTOPERATIVE WOUND INFECTION AND 13 CASES OF IMPLANT REMOVAL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448203 UNK - CONSTRUCTS: USS ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention