BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW NO LOCK D4.5X18MM

    MDR report key: 7148049 · Received December 27, 2017

    Report

    Report Number
    1818910-2017-52554
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 1, 2017
    Report Date
    November 30, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY : THE COMPLAINT DESCRIPTION REPORTS A REVISION DUE TO PAIN AND IMPINGEMENT. THE INFERIOR SCREW HAD SNAPPED, PROBABLY DUE TO MECHANICAL NOTCHING. NO PRODUCTS WERE RETURNED FOR THIS COMPLAINT. BASED ON THE INVESTIGATION PERFORMED NO PRODUCT DEFECT WAS IDENTIFIED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE DHR ANALYSIS OF THE BATCH 5241525/ PRODUCT CODE 130770018, SHOWS AN INITIAL CONFORMANCE OF THESE PRODUCTS WITH REGARDS TO THE SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR NON-CONFORMANCE. (B)(4) PARTS WERE MANUFACTURED IN NOVEMBER 2014. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REVISON REVERSE TOTAL SHOULDER , SURGEON; (B)(6), (B)(6) HOSPITAL (B)(6) 2017.ORIGINAL SURGERY WAS DONE AT (B)(6) IN (B)(6) 2015, BUT WAS REVISED DUE TO PAIN AND IMPINGEMENT. THE INFERIOR SCREW HAD SNAPPED, PROBABLY DUE TO MECHANICAL NOTCHING. REVISED TO A 42 ECCENTRIC GLENOSPHERE AND 42/9 HMO POLY. SIGNIFICANT LYSIS AROUND BOTH COMPONENTS AS A RESULT OF THE MECHANICAL NOTCHING. FEMALE PATIENT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929021 DXTEND SCREW NO LOCK D4.5X18MM SHOULDER IMPLANT KWS DEPUY ORTHOPAEDICS INC 1818910 5241525

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR