BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 28MM

    MDR report key: 4374441 · Received December 31, 2014

    Report

    Report Number
    2520274-2014-15678
    Event Type
    Injury
    Date Received
    December 31, 2014
    Report Date
    December 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK131186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS ARE (B)(6). ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. THE ACTUAL DATE OF IMPLANT IS UNKNOWN. THE COMPLAINANT PART WILL NOT BE RETURNED TO THE MANUFACTURER FOR REVIEW/INVESTIGATION. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 THE PATIENT SUSTAINED A RIGHT OLECRANON FRACTURE ON (B)(6) 2014. AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE WAS PERFORMED TO REPAIR THE INJURY. POST-OPERATIVE FOLLOW-UP REVEALED THE FRACTURE HAD HEALED; HOWEVER, SOFT TISSUE COVERAGE WAS COMPROMISED. THE PLATE WAS PROMINENT AND PAINFUL. ALSO, CLINICAL FINDINGS INDICATED THAT THIS WAS A POTENTIAL INFECTED INJURY SITE. DECISION WAS MADE TO REMOVE ALL OF THE HARDWARE AT THIS TIME. ALL HARDWARE WAS REMOVED WITHOUT COMPLICATION. THERE WAS NO SURGICAL DELAY. THIS REPORT IS 6 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861794 3.5MM CORTEX SCREW SELF-TAPPING 28MM SCREW, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention