BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: CMF

    MDR report key: 9950546 · Received April 10, 2020

    Report

    Report Number
    8030965-2020-02820
    Event Type
    Injury
    Date Received
    April 10, 2020
    Report Date
    March 20, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN TITANIUM PLATES FIXED/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: OU C, ET AL. (2019), CRANIOPLASTY USING POLYMETHYLMETHACRYLATE CEMENT FOLLOWING RETROSIGMOID CRANIECTOMY DECREASES THE RATE OF CEREBROSPINAL FLUID LEAK AND PSEUDOMENINGOCELE, THE JOURNAL OF CRANIOFACIAL SURGERY, VOLUME 30, NUMBER 2, PAGE 566-570, (CHINA). THE PRESENT STUDY INVESTIGATED THE EFFECTS OF CRANIOPLASTY USING POLYMETHYLMETHACRYLATE (PMMA) CEMENT TO REDUCE THE INCIDENCE OF CEREBROSPINAL FLUID LEAK FOLLOWING RETROSIGMOID CRANIECTOMY AS COMPARED WITH THE AUTOLOGOUS BONE FLAP COMBINED WITH TITANIUM PLATES. FROM JULY 2010 TO MAY 2017, 243 PATIENTS WHO UNDERWENT A RETROSIGMOID APPROACH-BASED SURGERY WERE INCLUDED IN THE STUDY. THERE WERE 151 FEMALES AND 92 MALES WITH A MEDIAN AGE OF 58.0 (RANGE, 25-85 YEARS). THE PATIENTS UNDERWENT 2 TYPES OF BONE RECONSTRUCTION AFTER DURA CLOSURE: COMPLETE CRANIOPLASTY USING THE PMMA CEMENT OR INCOMPLETE CRANIOPLASTY BY REPLENISHING THE AUTOLOGOUS BONE FLAP FIXED WITH TITANIUM PLATES. A TOTAL OF 136 PATIENTS UNDERWENT COMPLETE CRANIOPLASTY USING A COMPETITOR¿S PMMA CEMENT WHILE 107 PATIENTS UNDERWENT INCOMPLETE CRANIOPLASTY WITH AN AUTOLOGOUS BONE FLAP THAT WAS AFFIXED WITH AN UNKNOWN SYNTHES TITANIUM PLATES FIXED WITH AN UNKNOWN SYNTHES TITANIUM SCREWS. PATIENTS WERE EVALUATED AT DAY 1 POSTOPERATIVELY UNTIL THE LATEST FOLLOW-UP FOR COMPLICATIONS INCLUDING CSF LEAK (RHINORRHEA OR INCISIONAL), PSEUDOMENINGOCELE FORMATION, AND WOUND PROBLEMS SUCH AS INFECTION AND MATERIAL REJECTION. THE MEDIAN FOLLOW-UP TIME FOR THE AUTOLOGOUS BONE AND PMMA CEMENT GROUPS WAS 13 AND 12 MONTHS, RESPECTIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 9 PATIENTS HAD CEREBROSPINAL FLUID LEAKS (CSF). 7 OF THESE WERE INCISIONAL CSF LEAKS AND WERE TREATED BY OVERSEWING THE WOUND AND PROLONGED PRESSURE DRESSING AND 2 WERE RHINORRHEA THAT WAS TREATED BY LUMBAR DRAINAGE. 1 PATIENT HAD PERSISTENT RHINORRHEA AFTER 10 DAYS OF DRAINAGE AND UNDERWENT SURGICAL REPAIR OF THE LEAKING SITE. 11 PATIENTS HAD PSEUDOMENINGOCELES. PSEUDOMENINGOCELES WERE ASPIRATED WITH SYRINGES AND PRESSURE DRESSED UNTIL THE SUBCUTANEOUS FLUID COLLECTION DISAPPEARED. 2 PATIENTS HAD WOUND INFECTIONS. THIS REPORT IS FOR THE UNKNOWN SYNTHES TITANIUM PLATES FIXED. IT CAPTURES THE REPORTED EVENTS OF CEREBROSPINAL FLUID LEAKS (INCISIONAL OR RHINORRHEA), PSEUDOMENINGOCELES AND WOUND INFECTIONS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411992 UNK - PLATES: CMF PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention