BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW NO LOCK D4.5X18MM

    MDR report key: 4573065 · Received March 5, 2015

    Report

    Report Number
    1818910-2015-15381
    Event Type
    Injury
    Date Received
    March 5, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 11, 2015
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S
    Product Code
    HSD
    PMA / PMN Number
    PK120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, DECREASED MOBILITY AND LOOSENING OF THE METAGLENE AND GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154806 DXTEND SCREW NO LOCK D4.5X18MM SHOULDER OTHER IMPLANT HSD 3003895575 DEPUY FRANCE S.A.S 5227083

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention