BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA

    MDR report key: 10513538 · Received September 10, 2020

    Report

    Report Number
    8030965-2020-06711
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    August 21, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JEY
    UDI-DI
    07611819753730
    PMA / PMN Number
    K022012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. (B)(4). 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.

    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, 'STIEGLITZ, L. ET AL. (2015), WHAT HAPPENS TO THE BONE FLAP? LONG-TERM OUTCOME AFTER REIMPLANTATION OF CRYOCONSERVED BONE FLAPS IN A CONSECUTIVE SERIES OF 92 PATIENTS, ACTA NEURO-CHIRURGICA', VOL. 157, PAGES 275-280 (SWITZERLAND) HTTPS://DOI.ORG/10.1007/S00701-014-2310-7. THE OBJECTIVE OF THIS RETROSPECTIVE ANALYSIS WAS TO IDENTIFY THE INCIDENCE OF BONE FLAP RESORPTION, AND THE OPTIMAL DURATION OF FOLLOW-UP. BETWEEN FEBRUARY 2009 AND MARCH 2012, 92 PATIENTS (60 MALES AND 32 FEMALES) WITH A MEAN AGE WAS 46.2 YEARS WERE REIMPLANTED WITH CRYOCONSERVED AUTOLOGOUS BONE FLAPS USING TITANIUM PLATES AND SCREWS (LOW PROFILE NEURO 0.6MM SELF-DRILLING SCREWS, 4-5MM LENGTH), AND DOUBLE-Y- OR BURR-HOLE-COVER PLATES, 0.5MM THICK (SYNTHES, OBERDORF, SWITZERLAND). THE MEAN FOLLOW-UP TIME WAS 21.6 MONTHS. THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: 5 PATIENTS DIED BEFORE FOLLOW-UP; 1 PATIENT HAD INFECTION AFTER WOUND HEALING DISTURBANCE; 3 PATIENT HAD HEMATOMA; 12 PATIENTS HAD HYGROMA; 19 PATIENTS HAD HYDROCEPHALUS REQUIRING SHUNT PLACEMENT; 4 PATIENTS HAD DISLOCATION/COLLAPSE; 19 PATIENTS HAD MINOR RESORPTION WITH A SCORE OF 1-2; 28 PATIENTS HAD MAJOR RESORPTION WITH A SCORE OF 3 LEADING TO SURGICAL REVISION AND REPLACEMENT WITH A PATIENT-SPECIFIC IMPLANT; 27 PATIENTS SUBSEQUENTLY HAD A PSI IMPLANTATION; THIS REPORT IS FOR A BURR HOLE COVER 1.6 F/BURRHOLES-Ø24 T0.5). THIS IS REPORT 3 OF 4 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978622 TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA PLATE, BONE JEY OBERDORF SYNTHES PRODUKTIONS GMBH 07611819753730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention