BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8357476 · Received February 21, 2019

    Report

    Report Number
    8030965-2019-61208
    Event Type
    Injury
    Date Received
    February 21, 2019
    Report Date
    January 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. 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: G. SIEBENBURGER ET AL (2015), TIMING OF SURGERY FOR OPEN REDUCTION AND INTERNAL FIXATION OF DISPLACED PROXIMAL HUMERAL FRACTURES, INJURY PAGES S58-S62 (GERMANY). THE AIM OF THE STUDY THEREFORE WAS TO INVESTIGATE THE RELATIONSHIP BETWEEN TIMING OF SURGERY AND COMPLICATIONS ASSOCIATED TO FRACTURE HEALING FOLLOWING OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL HUMERAL FRACTURES. BETWEEN FEBRUARY 2002 AND NOVEMBER 2010, 497 PATIENTS WITH DISPLACED PROXIMAL HUMERAL FRACTURES (NEER CRITERIA) WERE INCLUDED. ALL FRACTURES WERE TREATED BY MEANS OF OPEN REDUCTION AND INTERNAL FIXATION. FOR ORIF SURGICAL RECONSTRUCTION OF THE HUMERAL HEAD WAS PERFORMED USING LOCKING PLATES (PHILOS®, SYNTHES DEPUY GMBH, OBERDORF, SWITZERLAND OR NCB-PH®, ZIMMER GMBH, WINTERTHUR, SWITZERLAND). OF THE 329 PATIENTS (225 WOMEN AND 104 MEN; MEDIAN AGE: 64.9) IN 151 CASES THE SURGERY WAS PERFORMED WITHIN 48H FROM TRAUMA, IN 135 CASES (41.0) BETWEEN 48H AND 4 DAYS, AND IN 43 CASES 5 DAYS OR LATER, RESPECTIVELY. THE FRACTURE PATTERNS ACCORDING TO NEER CLASSIFICATION WERE AS FOLLOWING: 2-PART FRACTURE = 126 PATIENTS, 3-PART FRACTURE = 136 PATIENTS, 4-PART FRACTURE = 43 PATIENTS, HEAD SPLIT TYPE FRACTURE = 11 PATIENTS AND DISLOCATION TYPE FRACTURE = 13 PATIENTS. THE STANDARDIZED FOLLOW-UP COMPRISED CLINICAL AND RADIOGRAPHIC EXAMINATIONS OF THE AFFECTED SHOULDER AT THREE, SIX AND 12 MONTHS AFTER SURGERY AS WELL AS AT FINAL FOLLOW-UP. THE MEDIAN FOLLOW UP WAS 4.5 YEARS AFTER SURGERY WITH A MINIMAL FOLLOW-UP OF 12 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 42 PATIENTS HAD LOSS OF FIXATION. OF THESE PATIENTS: 16 HAD SCREW CUTOUT. 20 HAD AVASCULAR NECROSIS OF THE HUMERAL HEAD. THIS REPORT IS FOR UNKNOWN SCREWS. IT CAPTURES THE REPORTED ADVERSE 42 PATIENTS HAD LOSS OF FIXATION. OF THESE PATIENTS: 20 HAD AVASCULAR NECROSIS OF THE HUMERAL HEAD. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151081 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention