BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM CORTEX SCREW SELF-TAPPING 30MM

    MDR report key: 12088737 · Received June 29, 2021

    Report

    Report Number
    2939274-2021-03319
    Event Type
    Injury
    Date Received
    June 29, 2021
    Report Date
    June 7, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982144812
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: KTW. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. 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

    IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 12 OF 15 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982712 2.7MM CORTEX SCREW SELF-TAPPING 30MM SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 202.830 10886982144812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2.7MM CORTEX SCREW SELF-TAPPING 30MM| 2.7MM CORTEX SCREW SELF-TAPPING 30MM| 2.7MM CORTEX SCREW SELF-TAPPING 30MM| 3.5 LCKNG ATTACH PL FOR 4.5 LCP PL/4 H| 3.5 LCKNG ATTACH PL FOR 4.5 LCP PL/4 H| 4.5 CURVED BROAD LCP PL 12 HOLES/229| 4.5MM CORTEX SCREW SELF-TAPPING 38MM| 4.5MM CORTEX SCREW SELF-TAPPING 40MM| 4.5MM CORTEX SCREW SELF-TAPPING 40MM| 4.5MM CORTEX SCREW SELF-TAPPING 50MM| 5.0 TI LCKNG SCR T25 SD 50 FOR IM NAILS| 9/125 DEG TI CANN TFNA 400/RIGHT - SILE| TFNA FENESTRATED SCREW 90MM - STERILE| UNK-TI LOCKING SCREW