BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8222479 · Received January 7, 2019

    Report

    Report Number
    8030965-2019-59500
    Event Type
    Injury
    Date Received
    January 7, 2019
    Report Date
    December 12, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PMA/510(K) NUMBER IS NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: PADOLINO A. ET AL 2018). "COMPARISON OF CFR-PEEK AND CONVENTIONAL TITANIUM LOCKING PLATES FOR PROXIMAL HUMERAL FRACTURES: A RETROSPECTIVE CONTROLLED STUDY OF PATIENT OUTCOMES. MUSCULOSKELETAL SURGERY. VOLUME 102. PAGE S49-S56 (ITALY). THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF THREE- AND FOUR-PART PROXIMAL HUMERAL FRACTURES (PHFS) TREATED WITH CARBON FIBER-REINFORCED POLYETHERETHERKETONE (CFR-PEEK OR METAL (TITANIUM) PLATES. BETWEEN JANUARY 2013 TO DECEMBER 2015, 42 PATIENTS WHO UNDERWENT INTERNAL FIXATION OF 3 AND 4 PART PROXIMAL HUMERAL FRACTURES ACCORDING TO NEER CLASSIFICATION WERE IDENTIFIED AND EVALUATED FOR THE STUDY. ACCORDINGLY, PATIENTS WERE DIVIDED INTO A CFR-PEEK GROUP AND A METAL GROUP. THE CFR-PEEK GROUP CONSISTED OF PATIENT WHO WERE IMPLANTED WITH A COMPETITOR¿S DEVICE. THE METAL GROUP CONSISTED OF 21 PATIENTS (7 MALES AND 14 FEMALES, AVERAGE AGE OF 55.8 YEARS (RANGE, 22-78 YEARS)) WHO WERE IMPLANTED WITH AN UNKNOWN SYNTHES PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE AND SCREWS. INTRAOPERATIVE FLUOROSCOPY WAS USED TO CHECK FRAGMENT REDUCTION, PLATE POSITION, AND THE LENGTH OF THE SCREWS. AT THE END OF THE "ROCEDURE", THE ARM WAS IMMOBILIZED IN A SLING FOR 4 WEEKS. ACTIVE MOBILIZATION WAS ALLOWED AFTER 6 WEEKS AND STRENGTH EXERCISES AFTER 8 WEEKS. MEAN FOLLOW-UP FOR THE METAL GROUP WAS 57.2 MONTHS (RANGE, 29-77). COMPLICATIONS WERE REPORTED AS FOLLOWS: 5 PATIENTS EXPERIENCED MODERATE POSTOPERATIVE PAIN. 7 PATIENTS EXPERIENCED POSTOPERATIVE MILD PAIN. UNKNOWN NUMBER OF PATIENTS HAD CORTICAL THINNING AT POSTOPERATIVE RADIOGRAPH AT THE LAST FOLLOW-UP. 9 PATIENTS HAD TUBEROSITY RESORPTION OF GREATER THAN 50 PERCENT AT POSTOPERATIVE RADIOGRAPH AT THE LAST FOLLOW-UP. 2 PATIENTS HAD VARUS OR VALGUS MALALIGNMENT OF THE HUMERAL HEAD. 3 PATIENTS HAD SCREW PERFORATION AND CUTOUT. A (B)(6) PATIENT WITH POOR BONE QUALITY HAD HUMERAL HEAD COLLAPSE AND REQUIRED REVISION WITH REVERSE PROSTHESES. THIS REPORT IS FOR UNKNOWN PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) SCREWS. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16939 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention