BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER2 PEEK ROD LRD BA 5.5X80

    MDR report key: 3216618 · Received July 10, 2013

    Report

    Report Number
    1526439-2013-20873
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NQP
    PMA / PMN Number
    PK073562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION NOTED BROKEN RODS. A FRACTURE ANALYSIS WAS PERFORMED TO FACILITATE A MORE DETAILED INVESTIGATION OF THE RETURNED DEVICES. RESULTS NOTED THAT THE FRACTURED SURFACES EXHIBITS DEFORMATION OF MATERIAL INDICATIVE OF RODS RUBBING AGAINST THE PEDICLE SCREW HEADS POST FRACTURE. NO OTHER DEFECTS OR ABNORMALITIES WERE IDENTIFIED DURING DEVICE EVALUATION. A REVIEW OF THE BELOW DEVICE HISTORY RECORDS (DHRS) ACKNOWLEDGED THAT NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. THE ROOT CAUSE IS UNDETERMINED. ALTHOUGH NO CONCLUSIONS CAN BE DRAWN, IT WAS NOTED FROM THE REPORTED EVENT DESCRIPTION THAT PATIENT HAD BEEN IN A CAR ACCIDENT AFTER INITIAL IMPLANTATION WHICH MAY HAVE CAUSED THE RODS TO BREAK. THEREFORE, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS PREVIOUSLY FUSED FROM L3-S1 WITH INTERBODY FUSION AT L3-L4. PATIENT EXPERIENCED L2-L3 ADJACENT LEVEL FAILURE AND SURGEON WAS DOING A REMOVAL / RE-FUSION OF L2-S1. WHEN REMOVING OLD HARDWARE, IT WAS DISCOVERED THAT TWO PEEK RODS HAD BEEN BROKEN BI LATERALLY AT THE L3 LEVEL. ALL HARDWARE WAS REMOVED AND RE-INSTRUMENTED WITH NEW HARDWARE AND TITANIUM RODS. IT WAS REPORTED THAT PATIENT HAD BEEN IN A CAR ACCIDENT AFTER INITIAL IMPLANTATION WHICH MAY HAVE CAUSED BREAKAGE. THIS MEDWATCH REPORT IS BEING FILED FOR THE FIRST BROKEN PEEK ROD. SEE MFG MEDWATCH REPORT NO. 1526439-2013-20874 FOR THE SECOND BROKEN PEEK ROD. CONCOMITANT DEVICES: EXPEDIUM POLY SCREWS, 179712745 X 6; EXPEDIUM POLY SCREWS, 179712740 X 2; EXPEDIUM PEEK SET SCREWS, 186782000 X 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316266 VIPER2 PEEK ROD LRD BA 5.5X80 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NQP DEPUY SYNTHES SPINE 5052232

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention