BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMP

    MDR report key: 14342470 · Received May 9, 2022

    Report

    Report Number
    2027467-2022-00026
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 11, 2022
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HTW
    UDI-DI
    00190376195780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H3: YES. H6: INVESTIGATION FINDINGS: 213. INVESTIGATION CONCLUSION: 67. H8: REUSE. ADDITIONAL INFORMATION: H10: A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY MANUFACTURING OR PROCESSING-RELATED IRREGULARITIES RELATED TO THE SCREW SHANK GEOMETRY, TULIP GEOMETRY, OR OTHER PHYSICAL FEATURES. QIR REPORTS INDICATE ALL INSPECTED FEATURES WERE ACCEPTABLE. MATERIAL CERTS WERE PRESENT FROM THE SUPPLIER ALONG WITH ALL OTHER COFC'S. ENGINEERING COULD NOT DUPLICATE THE ISSUE DURING IN-HOUSE TESTING. THE AWL AND DRILL BOTH FUNCTION WITH NO ISSUE, THE CENTER SHAFT SLIDES WITHIN THE SLEEVE WITHOUT INTERRUPTION. THE ROOT CAUSE IS UNKNOWN. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    BOTH THE AWL AND DRILL BENT WHILE TRYING TO PUT A LATERAL PLATE ON CAUSING A DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135677 AMP BIT, DRILL HTW ALPHATEC SPINE, INC. 117-160; 117-165 8394701;8645801 00190376195780

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown