BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 35MM THREAD LENGTH

    MDR report key: 5091808 · Received September 21, 2015

    Report

    Report Number
    2530088-2015-10589
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 9, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: AS PER EVENT DESCRIPTION THE TIP OF THE SCREW WAS DETACHED FROM THE SHAFT. THE PRESENT SCREW TIP NEITHER SHOWS DAMAGE NOR BREAKAGE ON THE TIP. BUT THE SCREW HEAD ASSEMBLY SHOWS SIGNIFICANT DAMAGE. THE 6.0MM MATRIX TI SCREW ASSEMBLY INCLUDES THREE PARTS: BODY 04_632_420_2, COLLET 04_632_420_3, D6.0 MATRIX SCREW 04_632_635_1.THE PEDICLE SCREW MATRIX 5.5 POLYAXIAL Ø6 PREASSEMBLED EXHIBIT POST PRODUCTION DAMAGE. THE SCREW HEAD 04_632_420_2 WAS FORCIBLY PUSHED DOWN OUT OF THE COLLET 04_632_420_3 AND REMAINS PARTIALLY STUCK ON D6.0 MATRIX SCREW 04_632_635_1. THE SD25 STAR DRIVE HEAD RECESS AND THE INNER DIAMETER OF THE COLLET SHOW SEVERE POST MANUFACTURING CAUSED DAMAGE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE DHR REVIEW SHOWS THAT THE IMPLANT MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTING. THE MANNER OF DAMAGE SHOWS THAT THE SD25 STAR DRIVE HEAD RECESS AND THE INNER DIAMETER OF THE COLLET WERE DAMAGED DURING FORCIBLE USE OF AN UNQUALIFIED INSTRUMENT. BASED ON OUR FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT RELATED CONDITION WAS DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY REVIEW: MANUFACTURE DATE: JUNE 24, 2011. ONE (1) NON-CONFORMANCE REPORT (NCR) FOR WRONG CONDITION CODE WAS DISCOVERED. DURING THE INTERVAL BETWEEN ORDERING AND RECEIPT OF RAW MATERIAL, THERE WAS A CHANGE ORDER INITIATED TO CHANGE CONDITION CODE FROM ANR TO SRR. THE NON-CONFORMANCE WAS DISPOSITIONED AS "USE AS IS" AND IS NOT RELEVANT TO COMPLAINT CONDITION BECAUSE RAW MATERIAL MEETS ALL MECHANICAL AND CHEMICAL REQUIREMENTS. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERNAL FIXATION PROCEDURE OF THE LUMBAR VERTEBRA ON (B)(6) 2015. DURING THE PROCEDURE, THE TIP OF THE SCREW DETACHED FROM THE SHAFT. THE SURGEON REMOVED THE BROKEN DEVICE AND REPLACED IT WITH A NEW ONE TO COMPLETE THE PROCEDURE. DUE TO THE INTRA-OPERATIVE EVENTS, THE PROCEDURE WAS PROLONGED BY NINETY (90) MINUTES. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622084 6.0MM TI MATRIX POLYAXIAL SCREW 35MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 6702941

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention