BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE SET SCREW

    MDR report key: 9498122 · Received December 19, 2019

    Report

    Report Number
    3006460162-2019-00080
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    October 29, 2019
    Report Date
    January 6, 2020
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    OSH
    PMA / PMN Number
    K160466
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: D4 UPDATED LOT NUMBER M69068-B. D4 UPDATED UDI (B)(4). H4 UPDATED 31 JAN 2017. H6 UPDATED METHOD 3331, 4109 AND 10. H6 UPDATED RESULTS 3207. H6 UPDATED CONCLUSION 4315 AND 50. COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. 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. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES: ITEM: 00-1003-4001, LARGE SET SCREW, LOT: UNKNOWN, ITEM: 00-1300-2850, 5.5/6.0 POLYAXIAL PEDICLE SCREW 8.0MM X 50MM, LOT: 160069-G, ITEM: 00-1300-0740, 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM, LOT: M849321-I, ITEM: 00-1300-0745, 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM, LOT: M78684-I. PRODUCT HAS BEEN RECEIVED BY ORTHOPEDIATRICS AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A SPINAL FUSION, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO SET SCREW LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291779 LARGE SET SCREW PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDOPATHIS SCOLIOSIS OSH ORTHOPEDIATRICS, INC N/A M69068-B

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention