BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANN SCREW + LT - 42MM

    MDR report key: 20085856 · Received August 28, 2024

    Report

    Report Number
    3012966183-2024-00010
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    May 19, 2023
    Report Date
    August 26, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00810040632594
    PMA / PMN Number
    K153575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PATIENT WAS PART OF A RETROSPECTIVE CLINICAL STUDY WHERE ADDITIONAL INFORMATION WAS PROVIDED 22 AUG 2024. PATIENT HAD ACTIVE INFECTION AT BOTH SURGICAL SITES AT 4 WEEKS POST-OP. ADDITIONAL MEDICATION PRESCRIBED AND A WOUND CARE TEAM WAS SEEN FOR FURTHER TREATMENT. PATIENT WAS RADIOGRAPHICALLY FUSED AT 3 MONTHS POST-OP, BUT INFECTION STILL PRESENT. PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2023 AT 4.5 MONTHS POST-OP TO ADDRESS WOUND HEALING COMPLICATIONS AND THE RISK OF OSTEOMYLITIS. NO NOTED HARDWARE FAILURES WERE OBSERVED FROM THE EXPLANTED DEVICES. PATIENT RETURNED TO NORMAL ACTIVITY 10 MONTHS POST-OP WITH COMPLETED WOUND HEALING AND NO REMAINING INFECTION. A HISTORICAL DATA ANALYSIS WAS CONDUCTED RETURNING NO ASSOCIATED COMPLAINTS, CAPAS, TRENDS, OR NONCONFORMITIES WITHIN THE LAST 24 MONTHS FOR THE TRAUMA SCREW SYSTEM RELATED TO INFECTIONS. NO LOT INFORMATION WAS PROVIDED AND THE DEVICES WERE DISCARDED; THEREFORE A DEVICE EVALUATION AND DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    TYBER MEDICAL BECAME AWARE OF AN ADVERSE EVENT AS PART OF A RETROSPECTIVE CLINICAL STUDY INTO OUR HEADED SCREW SYSTEM. PATIENT REPORTED TO CLINIC 4 WEEKS POST-OP WITH INFECTION AT THE SURGICAL SITES AND PRESCRIBED MEDICATION. PATIENT WAS RADIOGRAPHICALLY FUSED AT 3 MONTHS POST-OP. THE PATIENT RETURNED AT 4.5 MONTHS POST-OP WITH THE INFECTION PERSISTING. HARDWARE WAS REMOVED AT 4.5 MONTHS POST-OP. THE PATIENT FULLY HEALED FROM THE INFECTION AT THE 10 MONTH POINT. ADVERSE EVENT REPORTED FROM CLINIC: AT 4 WEEKS POST OPERATIVE THE PATIENT WAS PLACED ON CLINDAMYCIN 300MG TID FOR 10 DAYS DUE TO HISTORY OF DIABETES AND OPEN ULCERATIONS. THE EVENT WAS INTERMITTENT, MODERATE, SERIOUS, AND NOT LIFE THREATENING. THE ACTIONS TAKEN FOR THIS EVENT REQUIRED THERAPY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THIS EVENT WAS NOT RELATED TO THE TYBER MEDICAL TRAUMA SCREW SYSTEM. THE CLINDAMYCIN WAS DISCONTINUED, AND THE PATIENT WAS SENT TO WOUND CARE FOR ADDITIONAL FOLLOW-UP AND WOUND TREATMENT. THE PATIENT HAD A SECOND VISIT BECAUSE THEIR WOUNDS DID NOT HEAL WITH ASSISTANCE OF WOUND CARE. THE PATIENT WAS SUBSEQUENTLY BROUGHT BACK TO THE OR FOR REMOVAL OF HARDWARE, INCISION AND DRAINAGE, AND APPLICATION OF WOUND VAC. THE PATIENT IS NOW FOLLOWING WITH WOUND CARE AND SYMPTOMS HAVE RESOLVED. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464908 3.5MM TI CANN SCREW + LT - 42MM HEADED TRAUMA SCREW HWC TYBER MEDICAL 04.354.342 00810040632594

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other| R