BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAP, CANNULATED, 4.5 MM (STAINLESS STEEL)

    MDR report key: 7885781 · Received September 18, 2018

    Report

    Report Number
    2027467-2018-00067
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HWX
    UDI-DI
    00844856044005
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CANNULATED TAP FOUND THAT THE DISTAL TIP HAD FRACTURED AND BECAME SEPARATED FROM THE INSTRUMENT. INSPECTION UNDER MAGNIFICATION REVEALED CIRCULAR FRACTURE LINES INDICATIVE OF A TORSIONAL OVERLOAD. THE DETACHED TIP WHICH REMAINS POSITIONED WITHIN THE PATIENTS S1 WAS MANUFACTURED FROM 465SS (STAINLESS STEEL) AND IS CERTIFIED TO ASTM A564 SPECIFICATIONS. IT APPEARS THAT THIS OCCURRENCE IS LIKELY THE RESULT OF IMPLANTATION IN HARD DENSE BONE, WHICH REQUIRED AN INCREASED TORSIONAL LOAD THAT EXCEEDED THE DESIGN LIMITS OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AT THIS TIME. THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. UPON THE RECEIPT OF ADDITIONAL INFORMATION AND/OR THE RETURN OF THE ILLICO TAP A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THE PATIENT HAD EXTREMELY HARD BONE. THE TIP OF THE TAP WAS BROKEN AT S1 WHILE THE SURGEON WAS CREATING A HOLE INTO THE PEDICLE THROUGH THE DILATOR. REMOVAL OF THE DETACHED TIP WAS UNSUCCESSFUL. IT REMAINS ENTRAPPED WITHIN THE PATIENT'S S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725504 TAP, CANNULATED, 4.5 MM (STAINLESS STEEL) HWX HWX ALPHATEC SPINE, INC. 73715 6918102 00844856044005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other