BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7219343 · Received January 25, 2018

    Report

    Report Number
    1526439-2018-50072
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    December 1, 2017
    Report Date
    January 10, 2018
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). GTIN:UNKNOWN. 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.

    Description of Event or Problem · 1

    IN (B)(6) 2017, EXACT SURGERY DATE IS STILL REQUESTED, WAS IN A MALE PATIENT, BORN (B)(6), BMI 30, INDICATION SPONDYLODISCITIS LWK 2/3 POSTERIOR STABILIZATION BY USING VIPER PRIME, WAS MADE. STABILIZATION WITH 4 VIPER PRIME SCREWS FROM LWK 2 TO LWK 4. ALL SCREWS VERTECEM HAVE BEEN AUGMENTED WITH APPROX. 1 ML. THE PEDICLE SCREWS IN THE 2ND LWK LOOSENED UP BOTH AND ARE RIPPED OUT, SO THAT A REVISION SURGERY MUST BE PERFORMED AT THE (B)(6) 2018. THE SURGEON DOES NOT BACK IT ON SHORTCOMINGS OF THE SYSTEM, BUT ON THE OSTEOPOROTIC CONDITION OF THE PATIENT'S BONE, SO THAT HIS OPINION, ANY OTHER TYPE OF SUPPLY WOULD HAVE ACHIEVED A SIMILAR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64085 UNKNOWN UNKNOWN NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention