BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED

    MDR report key: 9868464 · Received March 23, 2020

    Report

    Report Number
    8030965-2020-02183
    Event Type
    Injury
    Date Received
    March 23, 2020
    Report Date
    February 25, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: MULTIPLE PATIENT INVOLVED IN THE STUDY. IMPLANTATION DATE UNKNOWN. THIS REPORT IS FOR AN UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BALLING, H. (2019), ADDITIONAL SACROPLASTY DOES NOT IMPROVE CLINICAL OUTCOME IN MINIMALLY INVASIVE NAVIGATION-ASSISTED SCREW FIXATION PROCEDURES FOR NONDISPLACED INSUFFICIENCY FRACTURES OF THE SACRUM, SPINE, VOL. 44 (8), PAGES 534-542, DOI: 10.1097/BRS.0000000000002899 (GERMANY). THE AIM OF THIS PROSPECTIVE SINGLE-CENTER COHORT STUDY IS TO COMPARE TWO MINIMALLY INVASIVE SURGICAL PROCEDURES FOR THE TREATMENT OF NONDISPLACED SACRAL INSUFFICIENCY FRACTURES AFTER FAILED CONSERVATIVE THERAPY GROUNDING ON THE NULL HYPOTHESIS THAT NAVIGATION-ASSISTED SCREW FIXATION (NSF) WITHOUT ADDITIONAL SACROPLASTY OR ANY USE OF REINFORCING BONE CEMENT IS INFERIOR TO NAVIGATION-ASSISTED SCREW FIXATION WITH ADDITIONAL SACROPLASTY (NSF + SP) OF SYMPTOMATIC FRACTURE SITES BY EVALUATING THE EXTENT OF POSTSURGICAL PAIN REDUCTION, IMPROVEMENT OF FRACTURE-RELATED DISABILITY, AND LENGTH OF POSTSURGICAL HOSPITAL STAY (NONINFERIORITY TRIAL). BETWEEN OCTOBER 2011 TO MAY 2017, A TOTAL OF 52 PATIENTS (4 MALE AND 48 FEMALE) WITH AN AVERAGE AGE OF 76 (36-39) YEARS, WITH 124 SACRAL FRACTURES, WERE TREATED BY NAVIGATION-ASSISTED SCREW FIXATION (NSF) WITHOUT ADDITIONAL SACROPLASTY OR ANY USE OF REINFORCING BONE CEMENT IS INFERIOR TO NAVIGATION-ASSISTED SCREW FIXATION WITH ADDITIONAL SACROPLASTY (NSF + SP). SURGERY WAS PERFORMED USING CANNULATED 7.3MM SCREWS (SYNTHES INC., OBERDORF, SWITZERLAND) IN, OR A COMPETITOR'S DEVICE COMBINED WITH WASHERS USING A NON-NAVIGATED CANNULATED SCREWDRIVER. THE FOLLOW-UP PERIOD IS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: NSF GROUP: 1 PATIENT HAD SUBFASCIAL HEMATOMA FORMATION BEING ADDRESSED BY SURGICAL EVACUATION ON POSTOPERATIVE DAY 9. 1 PATIENT HAD ¿PULL-OUT¿ SCREW LOOSENING. THIS REPORT IS FOR AN UNKNOWN SYNTHES 7.3MM CANNULATED SCREWS. THIS IS 1 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329773 UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED PLATE,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention