BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRALOK W/ ORTHOCORD VIOLET/BLUE, 5MM

    MDR report key: 829144 · Received March 16, 2007

    Report

    Report Number
    1221934-2007-00077
    Event Type
    Injury
    Date Received
    March 16, 2007
    Date of Event
    December 7, 2006
    Report Date
    March 15, 2007
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, IS UNAVAILABLE FOR EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE, THERE IS NO INTERNALLY ASSIGNABLE CAUSE OF THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF 194 DEVICES THAT WERE RELEASED TO DISTRIBUTION. PATIENT INFECTION OCCURRED AND RESULTED IN A REPEATED, OPEN PROCEDURE TO REPAIR THE TISSUE. A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THIS EVENT. IF HOWEVER, MORE INFORMATION IS RECEIVED THAT IS BOTH PERTINENT AND GERMANE TO THIS ISSUE, THAT INFORMATION WILL BE EVALUATED AND THE CONCLUSIONS WILL BE REFLECTED IN A FOLLOW-UP REPORT. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE REP IS REPORTING THAT A PATIENT HAD A ROTATOR CUFF REPAIR WITH THREE SPIRALOK ANCHORS. THE PATIENT HAD A RED SPOT 3 WEEKS POST-OP AND WAS TREATED FOR INFECTION. THE INFECTION DID NOT SUBSIDE, SO THE DOCTOR BROUGHT THE PATIENT IN AND DID AN OPEN SHOULDER CASE. NECROSIS OF THE SHOULDER AREA WAS OBSERVED IN THE SITE WHERE THE ANCHOR WAS PLACED. THE SURGEON DID A CULTURE AND CULTURE CAME BACK AS NEGATIVE, THOUGH THE AREA LOOKED FATTY AND PUS-FILLED. THE SURGEON PLACED A PROLENE SUTURE IN THE ROTATOR CUFF AND REPAIRED IT WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT. (SEE RELATED MDRS 1121934-2007-0076 AND 1221934-2007-0078).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRALOK W/ ORTHOCORD VIOLET/BLUE, 5MM SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK 222986 2918490

    Patients

    Seq Age Sex Outcome Treatment
    1 YR