BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AWL (STAINLESS STEEL)

    MDR report key: 7482962 · Received May 3, 2018

    Report

    Report Number
    2027467-2018-00023
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    April 4, 2018
    Report Date
    April 4, 2018
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HWJ
    UDI-DI
    00844856043961
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED DEVICE CONFIRMED THE DISTAL TIP, APPROXIMATELY .591 IN LENGTH HAS BEEN COMPLETELY SEPARATED/DETACHED FROM THE INSTRUMENT. UNDER MAGNIFICATION, THE FRACTURE PATTERNS REVEAL LATERAL FORCES WHERE APPLIED TO THE INSTRUMENT WHICH CAUSED THE Ø.20" TIP TO ENCOUNTER EXCESSIVE FATIGUE/STRESS.

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AT THIS TIME. THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ILLICO AWL IS A CANNULATED INSTRUMENT GROUND AT 15° TO FORM A SHARP TROCAR TIP INTENDED TO PENETRATE CORTICAL BONE DURING PEDICLE PREPARATION. THE SECTION RETAINED BY THE PATIENT IS MANUFACTURED FROM CUSTOM (B)(4) STAINLESS STEEL WHICH IS PROCESSED AND CERTIFIED TO ASTM (B)(4) SPECIFICATIONS.

    Description of Event or Problem · 1

    THE DISTAL TIP OF AN ILLICO AWL BROKE OFF DURING THE MIS CASE. THE DETACHED SECTION REMAINS CAPTURED WITHIN THE PATIENTS L5 PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327124 AWL (STAINLESS STEEL) HWJ HWJ ALPHATEC SPINE, INC. 73711 5148702 00844856043961

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other