BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH

    MDR report key: 4719300 · Received April 22, 2015

    Report

    Report Number
    2520274-2015-13311
    Event Type
    Injury
    Date Received
    April 22, 2015
    Report Date
    April 14, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2014. THE PROCEDURE PERFORMED WAS AN EXPLORATION OF L4-5 FUSION AREA WITH REMOVAL AND REINSERTION OF INSTRUMENTATION, DECOMPRESSION OF NERVE ROOT AND REMOVAL OF OLD INTER-BODY GRAFT FUSION, BOTH INTER-BODY AND POSTEROLATERAL WITH INTER-BODY DEVICE AND ALLOGRAFT MIXED WITH BONE MARROW ASPIRATION. THE L4 SCREW HEAD AND NUT WAS DISCONNECTED AND THE ROD WAS REMOVED. THIS ALLOWED FOR EXPOSURE OF THE BROKEN L5 SCREW WITH THE HEAD STILL VISIBLE. THE CAGE WAS IDENTIFIED LATERAL TO THE INTERSPACE AND HAD BACKED OUT. LOOSE FRAGMENTS OF THE OLD BONE GRAFT WERE REMOVED. THE PATIENT WAS IMPLANTED WITH ONE SCREW, ONE SPACER, ONE ROD, TWO LOCKING CAPS, CHRONOS GRANULES AND PUTTY. THE PATIENT WAS DISCHARGED ON (B)(6) 2014 AND IT WAS NOTED THAT THE PATIENT HAD IMMEDIATE IMPROVEMENT IN HER RIGHT LEG PAIN, IMPROVEMENT IN HER LOWER BACK PAIN AND WAS ABLE TO AMBULATE WITHOUT DIFFICULTY. ON (B)(6) 2015, IT WAS NOTED THE PATIENT WAS EXPERIENCING LEG AND CIRCULATION PROBLEMS AND WAS HAVING AN UNKNOWN SHOT IN HER LEFT KNEE ON (B)(6) 2015.THIS IS REPORT 4 OF 9 FOR COM-052788.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS STILL IN PAIN; EVERY STEP SHE TAKES HURTS. THE PATIENT HAD ANOTHER UNKNOWN SHOT IN HER LEG ON (B)(4), 2015. THIS IS REPORT 4 OF 13 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266385 6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention