BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANACRYL (L-LACTIDE/GLYCOLIDE) SUTURE

    MDR report key: 3072609 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04283
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K974299
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT SHOULDER SURGERY ON (B)(6) 2003 TO REPAIR A TYPE III SLAP LESION AND ARTHROSCOPIC DISTAL CLAVICLE EXCISION AND PANALOK 3.5MM ABSORBABLE ANCHOR SOFT TISSUE FIXATION DEVICE WITH SUTURES WERE IMPLANTED. THE PATIENT DEVELOPED FOCAL CHONDROLYSIS AND CARTILAGE ISSUES POSTOPERATIVELY, REQUIRING ADDITIONAL SURGERIES. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174920 PANACRYL (L-LACTIDE/GLYCOLIDE) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PANALOK ANCHOR FIXATION DEVICE