BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 7494951 · Received May 8, 2018

    Report

    Report Number
    8030965-2018-53619
    Event Type
    Injury
    Date Received
    May 8, 2018
    Report Date
    April 13, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION UNKNOWN. IM, TS. ET AL (2014)THE EFFICACY OF TITANIUM BURR HOLE COVER FOR RECONSTRUCTION OF SKULL DEFECT AFTER BURR HOLE TREPHINATION OF CHRONIC SUBDURAL HEMATOMA. KOREAN JOURNAL OF NEUROTRAUMA. VOLUME 10. NUMBER 2. PAGES 501-507. (KOREA) REPORTER ADDRESS AND TELEPHONE NUMBER UNKNOWN. IMPLANT DATE IS UNKNOWN. EXPLANT DATE IS UNKNOWN. THE 510K: THIS REPORT IS FOR AN UNKNOWN MATERIX NEURO SCREW /UNKNOWN LOT. PART AND LOT NUMBER 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. THE MANUFACTURE DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PATIENT CODE: THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. 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:IM, TS. ET AL (2014)THE EFFICACY OF TITANIUM BURR HOLE COVER FOR RECONSTRUCTION OF SKULL DEFECT AFTER BURR HOLE TREPHINATION OF CHRONIC SUBDURAL HEMATOMA. KOREAN JOURNAL OF NEUROTRAUMA. VOLUME 10. NUMBER 2. PAGES 501-507. ((B)(6)) THE OBJECTIVE OF THIS RETROSPECTIVE CLINICAL STUDY IS TO EVALUATE THE EFFICACY OF TITANIUM BURR HOLE COVER (BHC) AFTER BURR HOLE TREPHINATION OF CHRONIC SUBDURAL HEMATOMA (CSDH) BY COMPARING THE DEGREE OF BURR HOLE SITE DEPRESSIONS AND COMPLICATION RATES IN GROUP WITH GELFOAM PACKING ONLY (GPO) AND GROUP WITH TITANIUM BHC, AND THE COSMETIC AND FUNCTIONAL OUTCOMES AS EVALUATED FROM PATIENT'S ASPECTS. BETWEEN JANUARY 2009 AND DECEMBER 2013, 196 PATIENTS WITH BURR HOLES CASE WERE SELECTED. THERE WERE 132 MALES AND 64 FEMALES WITH THEIR AGES RANGED FROM 22 TO 92 YEARS OLD. THEY WERE ASSIGNED INTO TWO GROUPS. ONE GROUP WHICH CONSISTS OF 95 PATIENTS WAS RECONSTRUCTED USING AN UNKNOWN SYNTHES TITANIUM BHC OF EITHER 15 MM OR 17 MM IN SIZE WITH FIVE SCREW HOLES USED DEPENDING ON THE SIZE OF DEFECT FOR EACH BURR HOLE, AND WAS FIXED USING ONLY TWO OR THREE SELF-DRILLING SCREWS. THE MEAN FOLLOW-UP PERIOD AFTER BURR HOLE TREPHINATIONS WAS 20.65 WEEKS. COMPLICATIONS WERE REPORTED AS FOLLOWS: THERE WERE SEVEN PATIENTS WHO HAD SCALP DEPRESSIONS WITH A MEAN DEPTH OF 0.16±0.57 MM. AS PER TELEPHONE SURVEY, TWO PATIENTS HAD COSMETIC INFERIORITY COMPLEXES AND TWO PATIENTS EXPERIENCED FUNCTIONAL HANDICAPS. THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM LOW PROFILE NEURO BURR HOLE COVER AND UNKNOWN SYNTHES SELF-DRILLING SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN MATERIX NEURO SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339142 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention