BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS 130 DEGREE LOCKING CANNULATED INFANT BLADE 25MM X 0MM X 3-HOLE

    MDR report key: 7262409 · Received February 10, 2018

    Report

    Report Number
    3006460162-2018-00012
    Event Type
    Malfunction
    Date Received
    February 10, 2018
    Date of Event
    January 2, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HRS
    PMA / PMN Number
    K110959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A COPY OF THE X-RAYS WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INVESTIGATION OF THE DHR DID NOT REVEAL ANY PROCESS DEVIATIONS OR INDICATIONS OF MANUFACTURING VARIATIONS THAT WOULD CONTRIBUTE TO THE OBSERVED FAILURE MODE. THE PLATE WAS MADE TO SPECIFICATION AND THERE HAVE BEEN NO RECENT DESIGN CHANGES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES: CATALOGUE #: 00-0903-2518, 3.5MM SELF TAPPING CORTICAL SCREW W/ T15 HEXALOBE SIZE 18MM, LOT #: 170685-J; CATALOGUE #: 00-0903-2616, 3.5MM SELF TAPPING CORTICAL SCREW W/ T15 HEXALOBE SIZE 16MM, LOT #: 172065-J. FOREIGN SOURCE - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN LOCKING CANNULATED BLADE PLATE, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PLATE FRACTURE. THE PATIENT WAS PLACED IN A SPICA CAST FOR SIX WEEKS AND COMPLAINED OF PAIN AFTER THIRTEEN DAYS OF MOBILIZATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105652 ORTHOPEDIATRICS 130 DEGREE LOCKING CANNULATED INFANT BLADE 25MM X 0MM X 3-HOLE ORTHOPEDIATRICS BLADE PLATE SYSTEM HRS ORTHOPEDIATRICS, CORP N/A 162547

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Hospitalization| R