BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAGLENE POSITIONER PLATE

    MDR report key: 9882575 · Received March 26, 2020

    Report

    Report Number
    1818910-2020-09286
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 10, 2020
    Report Date
    March 10, 2020
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    UDI-DI
    10603295116448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: ADDED: DEVICE IDENTIFICATION (LOT #), INITIAL REPORTER NAME AND ADDRESS, DEVICE MANUFACTURE DATE AND EVALUATION CODES. PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE PROLONGED SURGERY AND INSUFFICIENT INFORMATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 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

    DELTA XTEND SURGERY - WANTED TO PLACE THE METAGLENE POSITIONING PLATE 2307-87-003 AND DRILL THE 2307-87-004 METAGLENE CENTRAL GUIDE PIN Ø 2.5 MM BY INSERTING IT THROUGH THE WHOLE OF THE PLATE. BUT THE PIN DIDN'T FIT THROUGH THE WHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345621 METAGLENE POSITIONER PLATE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES LXH DEPUY FRANCE SAS - 3003895575 2307-87-003 5081519 10603295116448

    Patients

    Seq Age Sex Outcome Treatment
    1