BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 10751045 · Received October 28, 2020

    Report

    Report Number
    8030965-2020-08306
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    May 22, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BANSAL, H., MITTAL, S., GUPTA, A., AND TRIKHA, V. (2020), ANALYZING THE MODIFIED USE OF A PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE IN EXTRA-ARTICULAR DISTAL-THIRD DIAPHYSEAL HUMERAL FRACTURES WITH SOME CONCERNS, INJURY, VOL. 51 (8), PAGE 1938, HTTPS://WWW.INJURYJOURNAL.COM/ARTICLE/S0020-1383(20)30428-9/FULLTEXT (INDIA). THE AIM OF THIS STUDY IS TO KNOW OF THE AUTHORS¿ EXPERIENCE IN REMOVAL OF PLATES IN THEIR PATIENTS WITH THEIR TIPS IN DOING THE SAME AND TO APPRECIATE AUTHOR¿S CONTRIBUTION FOR BRINGING OUT INSIGHT INTO THIS MODIFIED USE OF PHILOS, AS CERTAINLY IT HAS HELPED THEIR PRACTICE. BETWEEN AN UNKNOWN PERIOD, A TOTAL OF 10 PATIENTS, WITH AN UNKNOWN AGE, WERE TREATED WITH INVERTED PHILOS WITH MINIMAL INVASIVE ANTERIOR APPROACH. THE FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: IN 2 OUT OF 10 CASES, WHEN IMPLANT REMOVAL WAS ATTEMPTED, IT WAS VERY DIFFICULT TO REMOVE THE IMPLANT THROUGH THE SAME INCISION USED FOR PRIMARY SURGERY. IT WAS ALSO PRACTICALLY VERY DIFFICULT TO REMOVE THE ONE OF THE COLD WELDED LOCKING SCREWS FROM PHILOS THROUGH THE SAME INCISION CONSIDERING CLOSED PROXIMITY TO RADIAL NERVE AND BRACHIAL ARTERY DISTALLY WHICH REQUIRED US TO EXTEND THE INCISION MORE PROXIMALLY WITH DUE RISK OF INJURY TO MUSCULO-CUTANEOUS NERVE. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATE/SCREWS CONSTRUCTS AND UNKNOWN SCREWS. THIS REPORT IS FOR ONE (1) UNK - SCREWS: TRAUMA. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217486 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention