BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHIELDLOC 7.5MM

    MDR report key: 9395187 · Received December 2, 2019

    Report

    Report Number
    3006460162-2019-00067
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    October 25, 2019
    Report Date
    January 6, 2020
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    MBI
    PMA / PMN Number
    K130217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: H4 UPDATED 26 JUL 2013. H6 UPDATED METHOD 3331, 4114, 4115 AND 4109. H6 UPDATED RESULTS 3207. H6 UPDATED CONCLUSION 4315. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. REPORTED EVENT WAS NOT CONFIRMED. DHR WAS REVIEWED. NO DEVIATIONS OR REWORK WAS REPORTED. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS THERE WERE NO TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM NUMBER: 10-1008-1075, ARMORLINK 7.5MM, LOT NUMBER: F132729. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT WAS DISPOSED OF AT THE FACILITY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2019-00068.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING AN ACL CORRECTION, THE PATIENT UNDERWENT A REVISION DUE TO MIGRATION OF THE SCREW. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192205 SHIELDLOC 7.5MM FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ORTHOPEDIATRICS, INC N/A F13729

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention