BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 10748664 · Received October 28, 2020

    Report

    Report Number
    8030965-2020-08261
    Event Type
    Injury
    Date Received
    October 28, 2020
    Report Date
    October 1, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN SCREW/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN JANUARY 2012, AND JULY 2017. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHIU, Y.C. ET AL. (2019), COMPARISON OF IMPLANT FAILURE RATES OF DIFFERENT PLATES FOR MIDSHAFT CLAVICULAR FRACTURES BASED ON FRACTURE CLASSIFICATIONS, JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, VOL. 14, NUMBER 220, PAGES 1-7 (TAIWAN) HTTPS://DOI.ORG/10.1186/S13018-019-1259-X. THE AIM OF OUR STUDY WAS TO INVESTIGATE FAILURE RATES OF RECONSTRUCTION PLATE AND NON-RECONSTRUCTION PLATE, AND FIND THE BEST STRATEGY FOR IMPLANT SELECTION FOR DIFFERENT FRACTURE TYPES FOR MIDSHAFT CLAVICULAR FRACTURES. BETWEEN JANUARY 2012, AND JULY 2017, PATIENTS WITH MID-THIRD CLAVICLE FRACTURE WITH MORE THAN ONE SHAFT WIDTH OF DISPLACEMENT, MORE THAN 2 CM SHORTENING, AND IMPENDING OPEN FRACTURES UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION. THERE WERE 226 PATIENTS ENROLLED IN THE STUDY WITH 148 MALES AND 78 FEMALES WITH A MEAN AGE AT OPERATION OF 43.5 YEARS (13 TO 87). ONE HUNDRED FIFTY-NINE PATIENTS WERE TREATED WITH RECONSTRUCTION PLATES (LOCKING RECONSTRUCTION PLATE, AND 67 PATIENTS WERE TREATED WITH NON-RECONSTRUCTION PLATES. AMONG THE 67 PATIENTS, 19 WERE TREATED WITH LOCKING RECONSTRUCTION PLATES, 20 WITH DCPS, AND 28 WITH PRE-CONTOURED LCPS. IMPLANTS USED WERE LOCKING RECONSTRUCTION PLATE (SYNTHES, BOCHUM, GERMANY), DYNAMIC COMPRESSION PLATE (DCP), OR PRE-CONTOURED LOCKING COMPRESSION PLATE (LCP SUPERIOR CLAVICLE PLATE, SYNTHES, BOCHUM, GERMANY). THEIR MEAN FOLLOW-UP TIME WAS 60.3 WEEKS (27 TO 274). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD MALE PATIENT WITH MIDSHAFT CLAVILCULAR FRACTURE HAD AN OPEN REDUCTION AND FIXATION WITH RECONSTRUCTION PLATE. OBVIOUS BENDING OF PLATE WAS OBSERVED AT THE 6-WEEK FOLLOW-UP RADIOGRAPH. COMPLETE BREAK OF PLATE WAS FOUND AT THE 8-WEEK FOLLOW-UP RADIOGRAPH. THE PATIENT RECEIVED REOPERATION AND FIXATION WITH LOCKING PLATE. UNEVENTFUL BONE UNION WAS FOUND 12 WEEKS LATER. 31 PATIENTS HAD IMPLANT FAILURES, 4 PATIENTS HAD PLATE BREAKAGE, 18 PATIENTS HAD BENDING OF PLATE, 9 PATIENTS HAD SCREW LOOSENING. 8 OF THE PATIENTS RECEIVED REVISION SURGERIES WITH NON-RECONSTRUCTION PLATE FIXATION. ALL OF THEM ACHIEVED UNEVENTFUL BONE UNION AFTER AT LEAST 22 WEEKS FOLLOW-UP. FOR THE OTHER 23 PATIENTS WITH IMPLANT FAILURE WHO DID NOT RECEIVE REVISION SURGERY, 1 PATIENT DID NOT ACHIEVE BONE UNION UNTIL THE LAST FOLLOW-UP OPD AT 6 MONTHS AFTER OPERATION. 22 PATIENTS EXPERIENCED DELAYED UNION AND VARIOUS DEGREES OF MAL-UNION. THIS REPORT IS FOR A LOCKING RECONSTRUCTION PLATE (SYNTHES, BOCHUM, GERMANY), DYNAMIC COMPRESSION PLATE (DCP), PRE-CONTOURED LOCKING COMPRESSION PLATE (LCP SUPERIOR CLAVICLE PLATE, SYNTHES, BOCHUM, GERMANY). THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS IS REPORT 6 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211805 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention