BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM

    MDR report key: 5010327 · Received August 18, 2015

    Report

    Report Number
    2520274-2015-15277
    Event Type
    Injury
    Date Received
    August 18, 2015
    Report Date
    August 3, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK103243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S HEIGHT HAS BEEN REPORTED AS 5 FEET 2 INCHES. OLECRANON. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. THE COMPLAINANT PARTS ARE NOT EXPECTED TO BE RETURNED FOR MANUFACTURER INVESTIGATION. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE OF THE LEFT ELBOW DUE TO PAINFUL RETAINED HARDWARE AND INFECTION. ALL OF THE REMOVED HARDWARE, WHICH INCLUDED ONE (1) PLATE AND SEVEN (7) SCREWS, WAS INTACT. THE BONE APPEARED TO BE HEALED AND THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER REVISION. THE ORIGINAL IMPLANT PROCEDURE, TO REPAIR A FRACTURED OLECRANON, WAS PERFORMED ON (B)(6) 2014. THERE WAS NO REPORTED SURGICAL DELAY FROM EITHER OPERATION. THIS REPORT IS 7 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543997 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention