BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYS SS 480MM ROD, 160 KSI

    MDR report key: 4717938 · Received April 22, 2015

    Report

    Report Number
    1526439-2015-10315
    Event Type
    Injury
    Date Received
    April 22, 2015
    Report Date
    April 1, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK041119
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. SAMPLE NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    NOTIFIED THRU LEGAL: (B)(6) HAD A SPINAL FUSION PROCEDURE PERFORMED IN (B)(6) 2012. THE PROCEDURE INCLUDED IMPLANTED SPINAL RODS AND SCREWS MANUFACTURED BY DEFENDANTS. LESS THAN TWO YEARS LATER, IN APPROXIMATELY (B)(6) 2014, ONE OF THE IMPLANTED SPINAL RODS BROKE BETWEEN THE L2 AND L3 SCREWS, ACCORDING TO THE PERFORMING SURGEON. THE PERFORMING SURGEON HAS REFERRED PLAINTIFF TO A SURGEON IN MISSOURI FOR CORRECTIVE SURGERY. PLAINTIFF IS (B)(6) YEARS OLD, AND AS A RESULT OF THE ROD BREAKAGE HAS BEEN REDUCED TO A WHEELCHAIR WHEN MOVING ABOUT AWAY FROM HER HOME. SHE IS UNDERGOING PAIN MANAGEMENT DUE TO THE EXTREME PAIN CAUSED BY THIS INCIDENT. TO DATE, THE CORRECTIVE SURGERY HAS NOT BEEN PERFORMED DUE TO THE TIME AND EXPENSE REQUIRED AND DUE TO THE FACT THAT PLAINTIFFS' AUTISTIC 10 YEAR-OLD SON HAS HAD RECENT HEALTH PROBLEMS. (B)(6) SUFFERS FROM SEVERE, CONTINUOUS PAIN, AND SHE NO LONGER IS ABLE TO HAVE SEXUAL INTERCOURSE WITH HER HUSBAND, (B)(6). DEFENDANTS' ACTIONS AND THE BREAKAGE OF THE ROD THAT WAS IMPLANTED IN (B)(6) HAVE CAUSED (B)(6) TO ENDURE CONTINUOUS PAIN AND OTHER HEALTH PROBLEMS. SHE IS NOW UNABLE TO ENJOY THINGS TO THE EXTENT SHE DID PRIOR TO THE ROD BREAKAGE. PRIOR TO THE ROD BREAKAGE, PLAINTIFFS ENJOYED A SOMEWHAT NORMAL SEXUAL RELATIONSHIP. HOWEVER, THEY ARE NO LONGER ABLE TO ENGAGE IN SEX, AND AS A RESULT THEIR MARRIAGE UNION HAS SEVERELY DIMINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265886 HYS SS 480MM ROD, 160 KSI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention| S