BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PANALOK ANCHOR

    MDR report key: 9254808 · Received October 30, 2019

    Report

    Report Number
    1221934-2019-59312
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    October 24, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PRODUCTS: 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: IMHOFF, A., ET AL. (2010) "ARTHROSCOPIC REPAIR OF ANTERIOR-INFERIOR GLENOHUMERAL INSTABILITY USING A PORTAL AT THE 5:30-O'CLOCK POSITION: ANALYSIS OF THE EFFECTS OF AGE, FIXATION METHOD, AND CONCOMITANT SHOULDER INJURY ON SURGICAL OUTCOMES", THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 38, NO. 9, PAGES 1795-1803 (GERMANY). THIS STUDY EMPHASIZES ON ASSESSING WHICH FACTORS, INCLUDING CONCOMITANT INJURY (ROTATOR CUFF TEARS, SUPERIOR LABRAL ANTERIOR POSTERIOR [SLAP] LESIONS), PATIENT AGE, AND FIXATION METHODS, LED TO REDISLOCATION AFTER ARTHROSCOPIC STABILIZATION. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: BETWEEN 1996 AND 2000, 221 PATIENTS WERE TREATED WITH ARTHROSCOPIC STABILIZATION FOR ANTERIOR-INFERIOR SHOULDER DISLOCATION. OF THESE 221 CONSECUTIVE PATIENTS, 190 (140 MALE, 50 FEMALE) WITH AN AVERAGE AGE OF 28.0 YEARS (RANGE, 14.4-59.2 YEARS) WERE AVAILABLE FOR FOLLOW-UP (AVERAGE FOLLOW-UP, 37.4 ± 15.8 MONTHS). FIXATION METHODS WERE FASTAK (N = 138), SURETAC (N = 28), OR PANALOK (N = 24) ANCHORS. CONCOMITANT SLAP LESIONS WERE SEEN IN 38 OF 190 CASES (20%). REDISLOCATION RATES VARIED BETWEEN ANCHOR SYSTEMS (FASTAK, 6.5%; SURETAC, 25%; PANALOK, 16.8%). SUPERIOR LABRAL ANTERIOR POSTERIOR LESIONS, WHEN TREATED, DID NOT INFLUENCE CLINICAL OUTCOMES OR REDISLOCATION RATE. A CONCOMITANT ROTATOR CUFF TEAR DID NOT INFLUENCE REDISLOCATION RATE. POSTOPERATIVE OUTCOMES (ROWE SCORE. CONSTANT SCORE, AMERICAN SHOULDER AND ELBOW SURGEONS [ASES] SHOULDER INDEX, 12-ITEM QUESTIONNAIRE) IN PATIENTS WITH A PARTIAL TEAR WERE ALSO NOT ALTERED. ON THE OTHER HAND, THE REDISLOCATION RATE CORRELATED WITH PATIENT AGE AND NUMBER OF PRIOR DISLOCATIONS. RETURN TO SPORTS AT PREINJURY LEVEL WAS POSSIBLE IN 80% OF CASES. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ARTHROSCOPIC REPAIR OF ANTERIOR-INFERIOR GLENOHUMERAL INSTABILITY USING A PORTAL AT THE 5:30-O'CLOCK POSITION. THE DEVICES INVOLVED WERE: DIFFERENT SUTURE ANCHORS WERE USED DURING TREATMENT FOR ANTERIOR-INFERIOR GLENOHUMERAL INSTABILITY. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: PANALOK ANCHORS WERE PLACED IN 24 PATIENTS. IN THIS GROUP, 4 OF 24 PATIENTS SUSTAINED A REDISLOCATION (16.8%) AND 2 OF 24 A SUBLUXATION (8.3%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049673 UNKNOWN PANALOK ANCHOR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention