BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3991447 · Received August 8, 2014

    Report

    Report Number
    2520274-2014-12631
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ¿PLATING OF HUMERAL SHAFT FRACTURES: COMPARISON OF STANDARD CONVENTIONAL PLATING VERSUS MINIMALLY INVASIVE PLATING¿ (2012). OHA, C.¿W. ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH; 98, 54-60. THIS REFERS TO UNKNOWN SCREWS/UNKNOWN QUANTITY/UNKNOWN LOT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿PLATING OF HUMERAL SHAFT FRACTURES: COMPARISON OF STANDARD CONVENTIONAL PLATING VERSUS MINIMALLY INVASIVE PLATING¿ (2012). OHA, C.¿W. ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH; 98, 54-60. 51 PATIENTS WITH AN UNSTABLE HUMERAL SHAFT FRACTURE WERE COLLECTED, WHO WERE TREATED WITH MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) OR OPEN REDUCTION AND PLATE OSTEOSYNTHESIS (ORPO) FROM JANUARY 2003 TO APRIL 2009. MEAN AGES OF THE MIPO AND ORPO GROUPS WERE 39.6 YEARS (RANGE, 16-83) AND 42 YEARS (RANGE, 17-82) RESPECTIVELY. IN THE MIPO GROUP, THERE WERE 16 MALES AND 13 FEMALES AND IN THE ORPO GROUP 16 MALES AND 14 FEMALES. A LOCKING COMPRESSION PLATE (NARROW LCP-57 CASES, METAPHYSEAL LCP-2 CASES [MIPO GROUP], SYNTHES, (B)(4)) WAS USED IN ALL 59 PATIENTS. POST-OPERATIVE COMPLICATIONS INCLUDED: FOUR NON-UNIONS (ONE A (B)(6) MALE), ONE DEEP INFECTION, AND ONE SCREW LOOSENING (WHILE FRACTURE UNION PROGRESSED). THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW AND REFERS TO THE LOOSENING. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470904 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1