BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMPOSITE TRANSFIX 5 X 50MM

    MDR report key: 3233699 · Received July 18, 2013

    Report

    Report Number
    1220246-2013-00120
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K112040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT PART REMAINS IN THE PATIENT AND CANNOT BE RETURNED THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED, SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THIS DEVICE AS WELL AS THE OTHER TWO CONCOMITANT DEVICES ARE SUPPLIED STERILE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE POST-OPERATIVE INFECTION COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE FOR THIS TYPE OF EVENT IS A NOSOCOMIAL SOURCE OR PATIENT NON-COMPLIANCE WITH POST-OP WOUND CARE DIRECTIONS. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INITIAL ACL SURGERY WAS ON (B)(6) 2013. EVERYTHING WENT FINE. PATIENT DIDN'T REPORT ANY PROBLEMS DURING POST-OP TREATMENT. AT A LATER TIME, HE STARTED HAVING PAIN AND WENT TO A DIFFERENT HOSPITAL FROM WHERE THE INITIAL ACL WAS PERFORMED. THEY FOUND AN INFECTION WITH RHIZOPUS MICROSPORUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333479 BIO-COMPOSITE TRANSFIX 5 X 50MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1978S, TRANSFIX II DRILLPINS, LOT # UNKNOWN.| AR-5035TC-09, BIO-COMP INTER. SCREW, LOT UNKNOWN.