BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8358832 · Received February 21, 2019

    Report

    Report Number
    2939274-2019-56587
    Event Type
    Injury
    Date Received
    February 21, 2019
    Report Date
    January 28, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. 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: C. ONG ET AL (2012). OUTCOMES OF OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL HUMERUS FRACTURES MANAGED WITH LOCKING PLATES. THE AMERICAN JOURNAL OF ORTHOPEDICS. PAGE 407-412. (USA). THE PURPOSE OF THIS STUDY IS TO EVALUATE THE OUTCOMES AND COMPLICATIONS OF OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF 2-, 3-, AND 4-PART PROXIMAL HUMERUS FRACTURES USING A STANDARD MANAGEMENT PROTOCOL WITH LOCKING PLATES. FROM FEBRUARY 2003 TO JANUARY 2008, 63 PATIENTS WITH ACUTE PROXIMAL HUMERUS FRACTURES MANAGED WITH ORIF AND LOCKING PLATES WERE INCLUDED IN THIS STUDY. SIXTY-THREE ACUTE FRACTURES WERE IDENTIFIED IN 63 ADULTS (19 MEN, 44 WOMEN) MEAN AGE WAS 62 YEARS AND MEAN FOLLOW-UP WAS 19 MONTHS. THERE WERE 12 TWO-PART FRACTURES, 42 THREE-PART FRACTURES, AND 9 FOUR-PART FRACTURES. PROXIMAL HUMERUS LOCKING PLATE (SYNTHES, PAOLI, PENNSYLVANIA) WAS USED TO TREAT THE FRACTURES. PATIENTS WERE EVALUATED 1, 6, 12, 26, AND 52 WEEKS AFTER SURGERY. PATIENTS WERE FOLLOWED FOR A MINIMUM OF 12 MONTHS; WHEN CLINICALLY INDICATED, FOLLOW-UP WAS CONTINUED BEYOND 12 MONTHS. MEAN FOLLOW-UP FOR THE COHORT WAS 19 MONTHS (RANGE, 12-64 MONTHS). THE COMPLICATIONS WERE REPORTED AS FOLLOWS: SEVEN PATIENTS HAD SCREWS THAT PENETRATED THE HUMERAL HEAD. FIVE OF THE 7 HAD THESE SCREWS REMOVED (ROM AND SYMPTOMS IMPROVED SIGNIFICANTLY); THE OTHER 2 WERE ASYMPTOMATIC AND DID NOT REQUIRE HARDWARE REMOVAL. THIS REPORT IS FOR UNKNOWN SCREWS. THIS IS REPORT 10 OF 10 FOR (B)(4). ADDITIONAL COMPLICATIONS ARE CAPTURED ON RELATED COMPLAINTS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153467 SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention