BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWS

    MDR report key: 4243374 · Received November 11, 2014

    Report

    Report Number
    1526439-2014-12078
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    January 1, 2008
    Report Date
    October 16, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PUNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE REVIEW OF THE MAUDE AND MEDSUN DATABASES FOR NON-MANUFACTURER REPORTS FOR COUGAR LATERAL, FOUND A REPORT FOR AN INTERVERTEBRAL FUSION DEVICE (BRAND NOT SPECIFIED). THE REPORT SAYS IT WAS NOT SENT TO DEPUY. MEDWATCH REPORT NUMBER: MW5030181. PT HAD BACK SURGERY FOR BACK PAIN IN 2008, AT (B)(6). SOON AFTER SURGERY PT FELT "SOMETHING WAS NOT RIGHT" WITH HER BACK. ONE YR LATER, DR. (B)(6) CALLED PT TO INFORMED HER THAT HE HAD REC'D A LETTER REGARDING THE SCREWS AND CAGE IMPLANTED IN HER BACK WERE DEFECTIVE. THE DOCTOR STATED THE LETTER CAME FROM FDA. ON (B)(6) 2012, PT HAD A CT SCAN OF HER BACK WHICH REVEALED A NON-FUSION BETWEEN L4-S1 AND LOOSE SCREWS. ON (B)(6), PT REC'D A LETTER FROM DR. (B)(6) STATING "A FAILURE OF CONSTRUCT, WHICH COULD CAUSE COLLAPSING. " PT STATES SHE IS ON PAIN MEDICATION AND USES A WALKER. THE FOLLOWING MFG MEDWATCH REPORTS ARE BEING FILED FOR THE CAGE AND SCREWS INVOLVED IN THE EVENT: 1526439-2014-12077; 1526439-2014-12078.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725590 SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention