BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CANNULATED LOCKING CORTICAL SCREW, 50MM

    MDR report key: 6868102 · Received September 15, 2017

    Report

    Report Number
    3006460162-2017-00013
    Event Type
    Injury
    Date Received
    September 15, 2017
    Report Date
    July 15, 2019
    Manufacturer
    ORTHOPEDIATRICS
    Product Code
    HWC
    PMA / PMN Number
    K111086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED, AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF THE SCREW UNDER MAGNIFICATION SHOWED NO UNUSUAL FEATURES OR DAMAGE. MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS. CONCOMITANT MEDICAL PRODUCTS: ITEM: 00-0907-3745, 3.5MM CANNULATED LOCKING CORTICAL SCREW, 45MM, LOT: M32683. ITEM: 00-0907-2520. 3.5MM SELF TAPPING CORTICAL SCREW W/ T15 HEX, 20MM, LOT: 140493. ITEM: 00-0903-2618, 3.5MM LOCKING CORTICAL SCREW W/T15 HEX, 18MM, LOT: 5275604. ITEM: 00-0903-2510, 3.5MM SELF TAPPING CORTICAL SCREW W/ T15 HEX, LOT: 1276.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LOCKING PROXIMAL. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS AS THE REVISION PROCEDURE HAS NOT YET OCCURRED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A PROXIMAL FEMORAL PROCEDURE, THE PATIENT IS SCHEDULED FOR A REVISION SURGERY DUE TO SCREWS BACKING OUT OF THE CONSTRUCT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650913 3.5MM CANNULATED LOCKING CORTICAL SCREW, 50MM ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM HWC ORTHOPEDIATRICS N/A M36205

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R