BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 10792734 · Received November 5, 2020

    Report

    Report Number
    8030965-2020-08639
    Event Type
    Injury
    Date Received
    November 5, 2020
    Report Date
    October 9, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN SEPTEMBER 2012 AND FEBRUARY 2015. 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. (B)(4). 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: PLATH, J.E. ET AL (2019), LOCKING NAIL VERSUS LOCKING PLATE FOR PROXIMAL HUMERAL FRACTURE FIXATION IN AN ELDERLY POPULATION: A PROSPECTIVE RANDOMISED CONTROLLED TRIAL, BMC MUSCULOSKELETAL DISORDERS, VOL. 20 (20), PAGES 1¿13, (GERMANY). THE AIM OF THIS SINGLE CENTRE RANDOMISED CONTROLLED TRIAL/STUDY IS TO PROSPECTIVELY EVALUATE THE OUTCOMES OF ELDERLY PATIENTS WITH PHFS WHO WERE TREATED WITH EITHER A LOCKING PLATE OSTEOSYNTHESIS OR LOCKING NAIL OSTEOSYNTHESIS, IN A RANDOMISED CONTROLLED STUDY DESIGN. BETWEEN SEPTEMBER 2012 AND FEBRUARY 2015, A TOTAL OF 68 PATIENTS, WITH A MEAN AGE OF 75.6 YEARS (60¿92), WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE RANDOMISED TO TREATMENT USING A COMPETITOR'S DEVICE (LBN GROUP) OR PHILOS LOCKING PLATE SYSTEM (PROXIMAL HUMERUS INTER-LOCKING SYSTEM, DEPUY SYNTHES, SOLOTHURN, SWITZERLAND). ONLY 27 IN THE LBN AND 28 IN THE PHILOS GROUP COMPLETED THE FULL FOLLOW-UP. ALL DATA WERE COLLECTED BY AN INDEPENDENT OBSERVER AT 3, 6 AND 12 MONTHS POSTOPERATIVELY. FOLLOW-UP WAS CONDUCTED AT A MEAN OF 3.0 MONTHS, 5.9 MONTHS AND 12.8 MONTHS POSTOPERATIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PHILOS GROUP: 11 PATIENTS HAD A TOTAL OF 16 COMPLICATIONS. 2 PATIENTS HAD MALPOSITION OF IMPLANTS. IN NONE OF THESE CASES WAS THE SUB-OPTIMAL IMPLANT POSITIONING CONSIDERED TO REPRESENT A POTENTIAL MECHANICAL ISSUE FOR SHOULDER FUNCTION AND THEREFORE REVISION WAS NOT INDICATED IN ANY CASE. 2 PATIENTS HAD TUBEROSITY RESORPTION AND SECONDARY HUMERAL HEAD MIGRATION. 1 PATIENT HAD OSTEONECROSIS OF HUMERAL HEAD. 1 PATIENT HAD AXILLARY NERVE LESION. 1 PATIENT HAD ADHESIVE CAPSULITIS. IN 9 PATIENTS, REOPERATION WAS INDICATED FOR ONE OR MORE COMPLICATIONS. IN 7 OF THESE PATIENTS, FURTHER SURGERY WAS PERFORMED DURING THE FOLLOW-UP PERIOD SUCH AS IMPLANT REMOVAL AND ARTHROLYSIS (N=5) AND REVERSE TOTAL SHOULDER REPLACEMENT (N=2). 8 PATIENTS HAD LOSS OF REDUCTION OF HUMERAL HEAD WITH SCREW CUT-OUT. 1 PATIENT HAD LOSS OF REDUCTION OF GREATER TUBEROSITY. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATE/SCREWS CONSTRUCTS AND UNKNOWN SYNTHES SCREWS. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS IS REPORT 2 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260296 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention