BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOCORD

    MDR report key: 9266318 · Received November 1, 2019

    Report

    Report Number
    1221934-2019-59373
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    February 10, 2008
    Report Date
    October 29, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCT: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TOMLINSON D., ALTCHEK D., DAVILA J., CORDASCO F.,(2008), A MODIFIED TECHNIQUE OF ARTHROSCOPICALLY ASSISTED AC JOINT RECONSTRUCTION AND PRELIMINARY RESULTS, CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, VOLUME 466, PAGES 639-645 (USA) DOI 10.1007/SL 1999-007-0085-3. THIS STUDY EMPHASIZES TO DESCRIBE THE TECHNIQUE AND PRELIMINARY RESULTS IN 10 PATIENTS WHO HAVE UNDERGONE CORACOCLAVICULAR LIGAMENT RECONSTRUCTION FOR HIGH-GRADE AC SEPARATION. THE PATIENTS EVALUATED ON THE COURSE OF THIS STUDY: A TOTAL OF 12 PATIENTS WHO UNDERWENT ARTHROSCOPICALLY ASSISTED CORACOCLAVICULAR LIGAMENT RECONSTRUCTION WERE INCLUDED IN THE STUDY. TWO OF THE 12 PATIENTS WERE LOST TO FOLLOW-UP BEFORE THE 3-MONTH FOLLOW-UP POINT LEAVING 10 PATIENTS WITH A MEAN AGE OF 33.5 YEARS (RANGE, 16-58 YEARS). CONCOMITANT PROCEDURES AT THE TIME OF THE AC JOINT RECONSTRUCTION INCLUDED SUBACROMIAL DECOMPRESSION IN ONE PATIENT, SLAP REPAIR IN ONE PATIENT, LABRAL DEBRIDEMENT IN TWO PATIENTS, AND ROTATOR CUFF DEBRIDEMENT IN ONE PATIENT. A NUMBER 2 ORTHOCORD SUTURE (DEPUY (B)(4)) WAS RUN OVER A 3-CM SPAN AT EACH END OF THE TENDON IN A LOCKING FASHION THE MINIMUM FOLLOW-UP FOR INCLUSION WAS 3 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TWO PATIENTS DEVELOPED SUPERFICIAL WOUND CELLULITE THAT RESOLVED WITH A SHORT COURSE OF ORAL ANTIBIOTICS. THIS REPORT IS FOR AN UNKNOWN MITEK NUMBER 2 ORTHOCORD SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060687 UNKNOWN ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention