BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3983048 · Received August 6, 2014

    Report

    Report Number
    2520274-2014-12151
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    June 13, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    VOIGT, C., GEISLER, A., HEPP, P., SCHULZ, A., LILL, H. ARE PLOYAXIALLY LOCKED SCREWS. ADVANTAGEOUS IN THE PLATE OSTEOSYNTHESIS OR PROXIMAL HUMERAL FRACTURES IN THE ELDERLY? A PROSPECTIVE RANDOMIZED CLINICAL OBSERVATIONAL STUDY. JOURNAL OF ORTHOPAEDIC TRAUMA 2011; 25:596-602. THIS REPORT IS FOR AN UNKNOWN NONPOLYAXIALLY LOCKED SCREWS. 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. MEDWATCH SUBMITTED TO FDA ON (B)(4) 2014 BUT ONLY COMPLETED FIRST ACKNOWLEDGEMENT. FDA REQUESTED RE-SUBMISSION (B)(4) 2014. 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: VOIGT, C., GEISLER, A., HEPP, P., SCHULZ, A., LILL, H. ARE PLOYAXIALLY LOCKED SCREWS ADVANTAGEOUS IN THE PLATE OSTEOSYNTHESIS OR PROXIMAL HUMERAL FRACTURES IN THE ELDERLY? A PROSPECTIVE RANDOMIZED CLINICAL OBSERVATIONAL STUDY. JOURNAL OF ORTHOPAEDIC TRAUMA 2011; 25:596-602. OBJECTIVE IS TO EVALUATE THE RESULTS OF PLATE OSTEOSYNTHESIS USING EITHER POLYAXIAL OR NONPOLYAXIALLY LOCKED SCREW-PLATE SYSTEMS IN PROXIMAL HUMERAL FRACTURES IN THE ELDERLY. 28 PATIENTS WITH MEDIAN AGE 72 YEARS (60-87 YEARS) WERE TREATED WITH SYNTHES PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS) WITH NONPOLYAXIALLY LOCKED SCREWS. THE TIME FROM ACCIDENT TO SURGERY WAS AN AVERAGE OF ONE DAY. SIX PATIENTS HAD DIABETES MELLITUS TYPE II. SURGICAL TECHNIQUE STATES THAT TUBEROSITY FRAGMENTS WERE REDUCED WITH FIBER WIRE, AND THE HEAD FRAGMENT WAS REDUCED ON THIS STABLE BASE IN THE CASE OF A VARUS DEFORMITY OF THE FRACTURE. IN CASE OF A VALGUS-IMPACTED FRACTURE, THE HEAD FRAGMENT WAS REDUCED FIRST AND THE TRUBEROSITIES WERE ADAPTED. THEN, THE PLATE WAS POSITIONED AND FIXED WITH THE SHAFT SCREW. PLATE POSITION WAS CHECKED WITH IMAGE INTENSIFIER. SCREWS WERE PLACED IN A FIXED DIRECTION. TWO FURTHER SCREWS WERE INSERTED IN THE PLATES SHAFT. FINAL IMAGES WERE DONE TO ASSURE NO SCREWS VIOLATED THE SUBCHONDRAL BONE OF THE HUMERAL HEAD. DETAILED ANALYSIS OF COMPLICATIONS REVEALED ONE REOSTEOSYNTHESIS SECONDARY TO INITIAL PLATE MALPOSITION, SEVEN PATIENTS EXPERIENCED SECONDARY LOSS OF REDUCTION AND SCREW PERFORATION, FOUR HAD VARUS DEFORMITY, ONE GREATER TUBEROSITY DISPLACEMENT AND TWO AVASCULAR HEAD NECROSIS. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN NONPOLYAXIALLY LOCKED SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462049 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention