BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM

    MDR report key: 10455401 · Received August 26, 2020

    Report

    Report Number
    3006460162-2020-00096
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 26, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    PMA / PMN Number
    K150600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION, BECAUSE IT HAS BEEN SCRAPPED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2020-00097. REFERENCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PRIMARY PROCEDURE: L4-S1 POSTERIOR SPINAL FUSION IN MAY 2020. A REVISION SURGERY WAS PERFORMED 15TH JULY 2020. BILATERAL S1 RESPONSE UNIAXIAL SCREWS HAD BROKEN CLOSE TO TULIP HEAD OF SCREW. SET SCREWS REMAINED INTACT AND ATTACHED TO COCR 6.0MM ROD. ORIGINAL CONSTRUCT HAD BILATERAL UNIAXIAL 6MMX40MM SCREWS AT L4 AND L5. LEFT S1 7MMX35MM AND RIGHT S1 7MMX40MM. ALL SCREWS WERE REMOVED AND REPLACED DURING REVISION SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918784 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM PEDICLE SCREW NKB ORTHOPEDIATRICS, CORP 00-1300-0735

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6.0MM COCR ROD| BILATERAL UNIAXIAL 6MMX40MM SCREWS