BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 9X100MM

    MDR report key: 8173694 · Received December 18, 2018

    Report

    Report Number
    1526439-2018-51151
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    PMA / PMN Number
    K111571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). UDI: (01)UNAVAILABLE (11)UNKNOWN (10)UNKNOWN. DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. WITHOUT THE RETURN OF THE DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. SHOULD MORE INFORMATION AND/OR THE SAMPLE BE PROVIDED AT A LATER TIME, THIS COMPLAINT WILL BE REOPENED AND DEVICE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). PC: SURGICAL INTERVENTION. DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). THE SCREW WAS BROKEN AT ITS PROXIMAL 2ND THREAD. THE BROKEN PORTION OF THE SCREW WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE EXPERIENCED UNINTENDED/EXCESSIVE FORCES SUCH AS OVER-TORQUE WHILE IN USE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    BREAKAGE OF ROD AND SAI SCREW WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012180 VIPER TI SAI POLY 9X100MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH TBNSB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other