BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 7172901 · Received January 8, 2018

    Report

    Report Number
    8030965-2018-50142
    Event Type
    Injury
    Date Received
    January 8, 2018
    Report Date
    December 11, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE 50 PATIENTS. PATIENT ID/INITIALS AND WEIGHT ARE UNKNOWN. THE AGE RANGE WAS 15 TO 66 YEARS (MEAN AGE 22.9 ¬¬+ 9.1 YEARS). SEX: 15 MALES AND 35 FEMALES. THIS REPORT IS FOR AN UNKNOWN TITANIUM PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE: UNKNOWN. EXPLANT DATE: UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONTACT PHONE NUMBER AND EMAIL ADDRESS WERE NOT PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: WIDAR, F; ET AL (2017) INCIDENCE AND RISK FACTORS PREDISPOSING PLATE REMOVAL FOLLOWING ORTHOGNATHIC SURGERY. ORAL SURG ORAL MED ORAL PATHOL ORAL RADIOL, 124:3, 231-239. (SWEDEN) THIS IS A RETROSPECTIVE STUDY TO INVESTIGATE THE INCIDENCE AND REASONS FOR TITANIUM FIXATION PLATE REMOVAL FOLLOWING ORTHOGNATHIC SURGERY, IDENTIFY RISK FACTORS PREDISPOSING REMOVAL, AND EXPLORE IF DISCOMFORT WAS REDUCED POSTOPERATIVELY. MEDICAL RECORDS OF 404 CONSECUTIVE PATIENTS WHO HAD UNDERGONE ORTHOGNATHIC SURGERY BETWEEN FEBRUARY 2003 AND DECEMBER 2011 FOR DENTOFACIAL ANOMALIES WERE REVIEWED. TWO L-SHAPED FIXATION PLATES WERE INSERTED LATERAL TO THE NOSE APERTURE FOLLOWED BY 2 L-SHAPED FIXATION PLATES AT THE ZYGOMAXILLARY BUTTRESS (DEPUY SYNTHES, MATRIXORTHOGNATHIC, (B)(4); KLS MARTIN GROUP, (B)(4). TO VALIDATE THE DATA FROM MEDICAL RECORDS AND TO PERFORM AN ACCURATE SURVIVAL ANALYSIS, A QUESTIONNAIRE WAS SENT TO ALL PATIENTS. IN TOTAL, 323 PATIENTS RESPONDED TO THE QUESTIONNAIRE IN WRITING OR THROUGH A STRUCTURED TELEPHONE INTERVIEW, THUS FORMING THE SAMPLE POPULATION. THE AGE RANGE WAS 15 TO 66 YEARS (MEAN AGE 22.9 ¬¬+ 9.1 YEARS), AND THE STUDY POPULATION CONSISTED OF 188 FEMALES AND 135 MALES. THE FOLLOW-UP PERIOD FOR THE STUDY POPULATION FROM THE TIME OF ORTHOGNATHIC SURGERY UNTIL THE ENDPOINT WAS, ON AVERAGE, 4.6 YEARS, WITH A MAXIMUM FOLLOW-UP PERIOD OF 10.8 YEARS. THE INCIDENCE OF PLATE REMOVAL WAS 50 OF 323 CASES (15%) IN 15 MALES AND 35 FEMALES OF WHICH 33 WAS DUE TO INFECTION (66%). THE MAJOR RISK FACTORS FOR REMOVING PLATES IN RELATION TO INFECTION WERE SMOKING, SURGERY IN THE MANDIBLE AND NUMBER OF PLATES INSERTED IN THE MANDIBLE. ALL OF THE INFECTIONS WERE CONSIDERED SUPERFICIAL AND DIRECTLY ASSOCIATED WITH THE INSERTED TITANIUM PLATES. PLATES WERE ALSO REMOVED FOR TENDERNESS/PAIN (16%); EXPOSED PLATE (8%); DETACHED PLATE (6%); AESTHETICS (6%); AND OTHER REASONS (12%). OUT OF THE 50 PATIENTS WHO HAD THEIR PLATES REMOVED 92% EXPERIENCED RELIEF FROM THE INITIAL DISCOMFORT. THE REMAINING 8% OF THE PATIENTS DID NOT EXPERIENCE RELIEF FROM DISCOMFORT AND REPORTED MAINLY TENDERNESS AND PAIN IN THE EXTRACTION AREA. THIS IS 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TITANIUM PLATE. THIS REPORT IS FOR 50 UNKNOWN PATIENTS WHO HAD THEIR PLATES REMOVED, 66% FOR INFECTION, 16% FOR TENDERNESS/PAIN, 8% FOR EXPOSED PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15746 BONE PLATE JEY OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention