BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM X 8MM SCREW

    MDR report key: 17309783 · Received July 12, 2023

    Report

    Report Number
    2027754-2023-00027
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 6, 2023
    Report Date
    August 1, 2023
    Manufacturer
    OSTEOMED, LLC
    Product Code
    DZL
    UDI-DI
    00845694000758
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH PROVIDED THE SEX OF THE PATIENT AND THE BATCH/LOT NUMBER OF THE REPORTED DEVICE. THEREFORE, B3 AND D4 WERE UPDATED. INITIALLY IT HAD BEEN REPORTED THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT WAS LATER DETERMINED THE DEVICE HAD BEEN DISCARDED AND WAS NOT AVAILABLE FOR RETURN. THEREFORE, D9 WAS UPDATED. THE DEVICE HISTORY REPORT (DHR) WAS REVIEWED FOR THE LOT NUMBER PROVIDED. THE DHR CONFIRMED NO DISCREPANCIES WERE IDENTIFIED AND ALL PARTS WERE MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATION. PARTS WERE PACKAGED USING THE AUTOMATED PACKAGING MACHINE. NO DISCREPANCIES WERE FOUND IN THE LINE CLEARANCE FORM. AN IMAGE WAS PROVIDED BY THE CUSTOMER OF THE SCREW BEING MEASURED WITH A CALIPER. BASED SOLELY ON THE IMAGE PROVIDED BY THE CUSTOMER , IT APPEARS THE SCREW MAJOR DIAMETER MEASURED 2.6 MM, OR 0.102 IN. THE DRAWING OF THE SCREW WAS REVIEWED. BASED ON THE MEASUREMENT IN THE IMAGE PROVIDED BY THE COMPLAINANT, THE SCREW DID NOT MEET THE DIAMETER SPECIFICATIONS. A REVIEW OF ALL SAFETY SCREW DRAWINGS FOUND THAT THE MAJOR DIAMETER OF 0.102 INCHES CORRESPONDS THE 206-27XX DRAWING. IT IS POSSIBLE SCREW IDENTIFIED BY THE CUSTOMER WAS A 206-2708 SCREW THAT WAS PACKAGED AS A 206-2408 SCREW. HOWEVER, WITHOUT THE DEVICE, THIS COULD NOT BE CONCLUSIVELY DETERMINED. DURING FOLLOW UP REGARDING COMPLAINT DETAILS, IT WAS DETERMINED THAT THESE OSTEOMED SCREWS WERE PROVIDED IN THEIR PACKAGING TO ANOTHER MANUFACTURER WHO THEN IS LOADING THESE SCREWS INTO A KIT CONTAINING THAT MANUFACTURER'S IMPLANT. THESE SCREWS ARE BEING USED WITH THAT MANUFACTURER'S TMJ PROTHESIS/IMPLANT. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, IT WAS DETERMINED THE SCREWS WERE BEING USED OFF-LABEL.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE SURGERY, THE SURGEON NOTED THAT THE OSTEOMED SCREW WAS TOO LARGE TO FIT INTO THE PILOT DRILL HOLE. THE SURGEON NOTED THAT THE SCREW WAS LARGER AND REPORTED THIS TO THE SALES REPRESENTATIVE OF ANOTHER MANUFACTURER. THIS SALES REPRESENTATIVE NOTED THE OSTEOMED SCREW WAS LARGER WHEN COMPARING IT TO OTHER OSTEOMED SCREWS THAT WERE SENT IN THE KIT. THIS PROCEDURE WAS COMPLETED WITH ADDITIONAL SCREWS THAT HAD BEEN PROVIDED OF THE SAME TYPE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED, AND THE SURGERY WAS NOT PROLONGED. DURING THE COURSE OF FOLLOW UP, IT WAS DETERMINED THAT THESE OSTEOMED SCREWS WERE PROVIDED IN THEIR PACKAGING TO ANOTHER MANUFACTURER WHO THEN IS LOADING THESE SCREWS INTO A KIT CONTAINING THAT MANUFACTURER'S IMPLANT. THESE SCREWS ARE BEING USED WITH THAT MANUFACTURER'S TMJ PROTHESIS/IMPLANT. THIS IS OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250111 2.4MM X 8MM SCREW SCREW, FIXATION, INTRAOSSEOUS DZL OSTEOMED, LLC 206-2408 1172762 00845694000758

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other