BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL I/F CAGE LG 7

    MDR report key: 3305746 · Received August 23, 2013

    Report

    Report Number
    1526439-2013-24956
    Event Type
    Injury
    Date Received
    August 23, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 8, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK081917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED UNIPLATE 1 LEVEL PLATE, 20MM [PRODUCT CODE: 1897-01-020, LOT NO: ALKBBT] NOTED MODERATE SCRATCH MARKS ON THE FRONT SURFACE OF THE PLATE. ADDITIONALLY, ONE OF THE TWO LOCKING CAMS HAD DEFORMED HEXLOBES. NO OTHER ABNORMALITIES WERE OBSERVED. THE TWO (2) RETURNED UNIPLATE SELF DRILLING SCREWS, 14MM [PRODUCT CODE: 1897-07-014, LOT NO: APCBPT] NOTED MINOR WEAR MARKS AROUND THE EDGES OF THE HEXLOBES. NO OTHER PHYSICAL DEFECTS OR ABNORMALITIES WERE INDICATED DURING EVALUATION. THE CERVICAL I/F CAGE LG 7° [PRODUCT CODE: 1733-01-207] WAS NOT RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. (B)(4). NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A DHR REVIEW FOR THE CERVICAL I/F CAGE LG 7° [PRODUCT CODE: 1733-01-207] COULD NOT BE CONDUCTED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN AND IT WAS DISCARDED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. THE ROOT CAUSE OF THE SCREW PULLOUT IS UNDETERMINED. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: ALL CORRECTIONS DUE TO DEVICE NOT BEING MADE AVAILABLE TO MANUFACTURER. OTHER DEVICES INCLUDED IN THE EVENT WERE RETURNED AND INFORMATION WAS INCORRECTLY UPDATED TO THE PREVIOUS FOLLOW-UP FOR THIS REPORT. DEVICE AVAILABLE FOR EVALUATION CORRECTED TO NO. DEVICE EVALUATED BY MANUFACTURER CORRECTED TO NO. ALL METHODS REMOVED, RESULTS CORRECTED TO (B)(4)- NONE, CONCLUSION CORRECTED TO (B)(4)-DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. A DHR REVIEW FOR THE CERVICAL I/F CAGE LG 7° [(B)(4)] COULD NOT BE CONDUCTED AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN AND IT WAS DISCARDED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. THE ROOT CAUSE OF THE EVENT IS UNDETERMINED. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. DEVICE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS REVISION SURGERY WAS PERFORMED DUE TO DEVICE PULL OUT/LOOSENING AND A FRACTURED VERTEBRAL BODY. AS REPORTED, THE PLATE HAD COME OFF THE VERTEBRAL BODY AND A SCREW HAD SUBSIDED ON THE VERTEBRAL BODY. THE CERVICAL CAGE WAS LOOSE. THE EXPLANTED DEVICES INCLUDED ONE UNIPLATE PLATE, TWO UNIPLATE SELF DRILLING SCREWS, AND ONE CERVICAL I/F CAGE. SEE THE FOLLOWING MEDWATCH REPORTS FOR THE OTHER DEVICES INVOLVED IN THE EVENT: 1526439-2013-24953, 1526439-2013-24954, 1526439-2013-24955.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410038 CERVICAL I/F CAGE LG 7 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention