BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS LCB CHILD PLATE, 3.5MM, 45MM X 0MM X 4-HOLE

    MDR report key: 7715743 · Received July 24, 2018

    Report

    Report Number
    3006460162-2018-00055
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    June 21, 2018
    Report Date
    November 22, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HRS
    UDI-DI
    0084113211029
    PMA / PMN Number
    K110959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: H4 UPDATED 01 MAY 2014. H6 UPDATED 10, 4109 AND 3331. H6 UPDATED 3252. H6 UPDATED 4315. THE RETURNED COMPONENT WAS EXAMINED AND FOUND TO BE MADE TO SPECIFICATIONS WITH NO RECENT DESIGN CHANGES. A FRACTURE WAS NOTED AS STATED IN THE COMPLAINT WITH THE FRACTURE OCCURRING THROUGH THE PROXIMAL PORTION OF THE PROXIMAL COMPRESSION SLOT. DHR REVIEW WAS PERFORMED AND THERE WERE NO FINDINGS THAT WOULD LEAD TO THE COMPLAINT CONDITION REPORTED. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). CONCOMITANT MEDICAL PRODUCTS - ITEM: 00-0903-2522, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 22MM, LOT: 140613; ITEM: 00-0903-2630, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 30MM, LOT: 170695-J; ITEM: 00-0903-2622, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 22MM, LOT: I02TR; ITEM: 00-0903-2622, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 22MM, LOT: 162095-J; ITEM: 00-0903-2522, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 22MM, LOT: 152073-J. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT APPROXIMATELY TWO MONTHS FOLLOWING THE IMPLANTATION OF A LOCKING CANNULATED BLADE PLATE SYSTEM, THE PATIENT EXPERIENCED PAIN. AN X-RAY WAS TAKEN AND IT WAS DISCOVERED THAT THE LCB PLATE WAS FRACTURED. PATIENT UNDERWENT A REVISION PROCEDURE AND THE SYSTEM WAS REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557481 ORTHOPEDIATRICS LCB CHILD PLATE, 3.5MM, 45MM X 0MM X 4-HOLE LOCKING CANNULATED BLADE PLATE HRS ORTHOPEDIATRICS, INC N/A 140213 0084113211029

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention SEE H10.