BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 22MM

    MDR report key: 5316475 · Received December 21, 2015

    Report

    Report Number
    2520274-2015-18021
    Event Type
    Injury
    Date Received
    December 21, 2015
    Report Date
    December 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PPREADMT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, DISCARDED BY HOSPITAL. ADDITIONAL 510K - K131186. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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

    IT WAS REPORTED THAT A SURGEON REMOVED A 3.5MM LOCKING COMPRESSION PLATE (LCP) HOOK PLATE AND THREE SCREWS FROM AN OLECRANON OSTEOTOMY PLATED AS PART OF AN OPEN REDUCTION INTERNAL FIXATION(ORIF) DISTAL HUMERUS ON (B)(6) 2015. NONE OF THE IMPLANTS WERE BROKEN OR DAMAGED. THE PATIENT HAD REPORTEDLY FALLEN TWICE SINCE THE INITIAL SURGERY, SLIGHTLY DISPLACING THE OSTEOTOMY. THE SURGEON WANTED TO RE-REDUCE THE OSTEOTOMY AND RE-PLATE WITH THE 3.5MM LCP OLECRANON PLATE. THE OSTEOTOMY WAS PARTIALLY HEALED, BUT HE TOOK DOWN THE CALLUS, AND RE-REDUCED IT. THERE WAS NO SIGN OF INFECTION. THE PATIENT FELL TWICE ON THE OPERATIVE ELBOW, WITHOUT BREAKING ANY HARDWARE. THE PATIENT COMPLAINED OF PAIN AFTER THE FALLS, WHICH LED TO THE ADDITIONAL SURGERY. THIS COMPLAINT INVOLVES FOUR DEVICES. IT WAS REPORTED THAT A SURGEON REMOVED A 3.5MM LOCKING COMPRESSION PLATE(LCP) HOOK PLATE AND (3)SELF-TAPPING CORTEX SCREWS FROM AN OLECRANON OSTEOTOMY ON (B)(6) 2015. THE OLECRANON OSTEOTOMY WAS PLATED AS PART OF AN OPEN REDUCTION INTERNAL FIXATION(ORIF) DISTAL HUMERUS ON (B)(6) 2015. THERE WERE NO SURGICAL DELAYS AND NO ADDITIONAL X-RAYS, OTHER THAN C-ARM CONFIRMATION OF THE REMOVAL INTRAOPERATIVELY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839906 3.5MM CORTEX SCREW SELF-TAPPING 22MM SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention