BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CMF

    MDR report key: 10432166 · Received August 20, 2020

    Report

    Report Number
    8030965-2020-06190
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    February 25, 2019
    Report Date
    July 27, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CMF SCREWS/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: BALASUNDRAM S, ET AL. (2020), A 4-YEAR MULTICENTRE AUDIT OF COMPLICATIONS FOLLOWING ORIF TREATMENT OF MANDIBULAR FRACTURES, J. MAXILLOFAC. ORAL SURG., VOLUME 19, PAGE 289-297, (MALAYSIA) THIS STUDY IS AIMED TO ASCERTAIN THE TYPES OF COMPLICATIONS AND ASSOCIATED FEATURES ARISING FROM OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF MANDIBULAR FRACTURES AND TO ELUCIDATE IF DIFFERENT OSTEOSYNTHESIS PLATING SYSTEMS VARY IN TREATMENT OUTCOME. FROM JANUARY 01, 2009 TO DECEMBER 31, 2012, 593 PATIENTS WITH MANDIBULAR FRACTURE THAT WERE TREATED WITH SURGICAL INTERVENTION (OPEN REDUCTION INTERNAL FIXATION) WERE INCLUDED IN THE STUDY. 88 PERCENT WERE MALES AND 12 PERCENT WERE FEMALES, RANGING IN AGE FROM 19 TO 32 YEARS (MEDIAN = 22 YEARS). THERE WERE 369 PATIENTS WHO WERE IMPLANTED WITH AN UNKNOWN SYNTHES COMPACT 2.0 LOCK MANDIBLE PLATING SYSTEM, 26 PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES MATRIXMANDIBLE PLATING SYSTEM WHILE THE REST OF THE PATIENTS WERE IMPLANTED WITH COMPETITORS¿ DEVICES. THE FOLLOW-UP TIME TO DECEMBER 2012 RANGED FROM 30 TO 230 DAYS (MEDIAN 72 DAYS). COMPLICATIONS WERE REPORTED AS FOLLOWS: A TOTAL OF 137 PATIENTS HAD COMPLICATIONS AFTER SURGERY. 29 HAD COMPLICATIONS AT LESS THAN 1 WEEK AFTER SURGERY, 63 PATIENTS HAD COMPLICATIONS FROM 1-6 WEEKS AFTER SURGERY WHILE 45 PATIENTS HAD COMPLICATIONS AT MORE THAN 6 WEEKS AFTER SURGERY. 40 PATIENTS HAD NERVE INJURY. 34 PATIENTS HAD SURGICAL SITE INFECTION. 29 PATIENTS HAD MILD OCCLUSAL DERANGEMENT. 18 PATIENTS HAD PLATE EXPOSURE. 18 PATIENTS HAD SCREW LOOSENING. 15 PATIENTS HAD WOUND DEHISCENCE. 3 PATIENTS HAD SEVERE OCCLUSAL DERANGEMENT. 5 PATIENTS HAD OTHER COMPLICATIONS. OF THESE PATIENTS, 96 WERE IMPLANTED WITH THE UNKNOWN SYNTHES COMPACT 2.0 LOCK MANDIBLE PLATING SYSTEM WHILE 1 WAS IMPLANTED WITH THE UNKNOWN SYNTHES MATRIXMANDIBLE PLATING SYSTEM. THIS REPORT IS FOR AN UNKNOWN SYNTHES CMF SCREWS. IT CAPTURES THE REPORTED EVENT OF SCREW LOOSENING. THIS IS REPORT 5 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898896 UNK - SCREWS: CMF SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention