BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN LOCK-PLATE TI 10MM

    MDR report key: 16973871 · Received May 22, 2023

    Report

    Report Number
    3012447612-2023-00168
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Report Date
    July 9, 2024
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWP
    UDI-DI
    00887868168208
    PMA / PMN Number
    K131156
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN G1 AND H3. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. INSPECTION: THE RETURNED DEVICE WAS EXAMINED. VISUAL INSPECTION REVEALED THE RECEIVED DEVICE IS PART NUMBER 6201-0014-001 LOT TC02407 AND THE OPEN PACKAGE RECEIVED IS FOR PART NUMBER 6201-0010-001 LOT TC251782-0. DHR REVIEW: THE DHR WAS REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT HIGHRIDGE MEDICAL¿S CONTROL. POTENTIAL ROOT CAUSE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO PACKAGING OR INSPECTION ERROR. DEVICE USAGE THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED THAT A 14MM ASPEN LOCK PLATE WAS PACKAGED AND LABELED AS A 10MM ASPEN LOCK PLATE. THIS WAS FOUND DURING INSPECTION UPON DELIVERY FROM THE DISTRIBUTION CENTER. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED THAT A 14MM ASPEN LOCK PLATE WAS PACKAGED AND LABELED AS A 10MM ASPEN LOCK PLATE. THIS WAS FOUND DURING INSPECTION UPON DELIVERY FROM THE DISTRIBUTION CENTER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780929 ASPEN LOCK-PLATE TI 10MM LANX SPINAL FIXATION SYSTEM KWP ZIMMER BIOMET SPINE INC. NA TC251782-0 00887868168208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose