BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM X 6MM AUTODRIVE SCREW

    MDR report key: 18466304 · Received January 8, 2024

    Report

    Report Number
    2027754-2024-00015
    Event Type
    Injury
    Date Received
    January 8, 2024
    Report Date
    January 8, 2024
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HWC
    UDI-DI
    00845694002448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE RECEIVED ON (B)(6) 2023 FOR EVALUATION. REVIEW OF THE DHRS REVEALED NO ANOMALIES. ADDITIONALLY, REVIEW OF MATERIAL COMPOSITION OF THE DEVICES AS WELL AS MANUFACTURING PROCESSES INDICATED NO CHANGES TO EITHER SINCE RELEASE OF THESE PRODUCTS. AS RECEIVED, THE FOUR (4) PLATES WERE FRACTURED, AND VISUAL INSPECTION REVEALED SOME WARPING ON THE PLATES. IT IS UNKNOWN IF THIS WARPING OCCURRED DUE TO THE REPORTED EVENT, DURING THE INITIAL IMPLANT SURGERY, OR DUE TO EXPLANT DAMAGE. VISUAL INSPECTION OF THE RETURNED SCREWS REVEALED NO ANOMALIES. THE RETURNED PARTS WERE GIVEN TO QC INSPECTION FOR EVALUATION AGAINST THE ENGINEERING DRAWINGS, AND ALL DEVICES MET SPECIFICATIONS. A TWO-YEAR REVIEW OF THE COMPLAINT DATABASE FOR THE 211-20XX PART FAMILY REVEALED ONLY ONE (1) COMPLAINT FOR POST-OP PLATE BREAKAGE- WHICH IS THE COMPLAINT WITHIN THIS REPORT. SIMILARLY, REVIEW OF THE COMPLAINT DATABASE FOR PART NUMBER (B)(6) REVEALED ONE (1) COMPLAINT FOR POST-OP PLATE BREAKAGE (WHICH IS THE COMPLAINT IN THIS REPORT). POTENTIAL CAUSES FOR POST-OP PLATE BREAKAGE INCLUDE IMPROPER MATERIAL SELECTION/STRENGTH, USER ERROR-IMPROPER FIXATION TECHNIQUE, PATIENT NONCOMPLIANCE WITH POST-OP INSTRUCTIONS, EXCESSIVE BENDING WHILE CONTOURING PLATES, IMPROPER PLATE SIZE SELECTION, AND NO/SLOW OSTEOGENESIS, OSTEOLYSIS, BONE RESORPTION. HOWEVER, BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED. ORIGINAL REPORT WAS SUBMITTED: REPORT NUMBER 2027754-2023-00054. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 22 DECEMBER 2023, IT WAS REPORTED ADDITIONAL DEVICES WERE INVOLVED, THEREFORE, THE FOLLOWING RELATED REPORTS HAVE BEEN SUBMITTED: 2027754-2024-00002, 2027754-2024-00003, 2027754-2024-00004, 2027754-2024-00005, 2027754-2024-00006, 2027754-2024-00007, 2027754-2024-00008, 2027754-2024-00009, 2027754-2024-00010, 2027754-2024-00011, 2027754-2024-00012, 2027754-2024-00013, 2027754-2024-00014, 2027754-2024-00015, 2027754-2024-00016, 2027754-2024-00017, 2027754-2024-00018, 2027754-2024-00019, AND 2027754-2024-00020.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2023 REGARDING THE PATIENT AND THE REPORTED EVENT. IT WAS REPORTED THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2023, AND 12 DAYS AFTER SURGERY (EVENT DATE (B)(6) 2023), A RADIOGRAPHIC EXAMINATION WAS PERFORMED WHERE IT WAS CONFIRMED THAT THE FIXED PLATES WERE BROKEN. ON (B)(6) 2023, A NEW SURGERY WAS PERFORMED, WHERE THE MATERIAL WAS EXPLANTED, AND A NEW MATERIAL WAS IMPLANTED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950153 2.0MM X 6MM AUTODRIVE SCREW SCREW, FIXATION, BONE HWC OSTEOMED, LLC 211-2006 1172397 00845694002448

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other