BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH

    MDR report key: 5886630 · Received August 18, 2016

    Report

    Report Number
    2520274-2016-14202
    Event Type
    Injury
    Date Received
    August 18, 2016
    Report Date
    August 1, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED 6.0MM MATRIX POLYAXIAL SCREW WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE SCREW WAS RETURNED DISASSEMBLED (POLYAXIAL HEAD SEPARATED FROM THE SCREW BODY). MINOR WEAR WAS NOTED ON THE SCREW BODY CONSISTENT WITH IMPLANTATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. ADDITIONALLY THE CONCOMITANT DEVICES (LOCKING CAPS: 09.632.099 LOTS H044667, H041686 AND 9977784) WERE RETURNED WITHOUT ALLEGATION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THE DEVICES CONTRIBUTED TO THE COMPLAINT CONDITION. PER THE TECHNIQUE GUIDE, THE MATRIX POLYAXIAL SCREW (04.632.645) IS UTILIZED IN MATRIX DEFORMITY AND MATRIX DEGENERATIVE AS PART OF THE POSTERIOR PEDICLE SCREW AND ROD FIXATION SYSTEM. POLYAXIAL SCREWS ARE AVAILABLE IN 4.0MM, 5.0MM, 5.5MM, 6.0MM, 7.0MM, 8.0MM AND 9.0MM DIAMETERS AND LENGTHS RANGING FROM 20-100MM. RELEVANT DRAWINGS FOR THE RETURNED IMPLANTS WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): TOP LEVEL, BODY AND 6.0MM MATRIX SCREW. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED IMPLANT¿S LOT NUMBER AND NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). AN IMAGE READING OF THE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER. THE MEDICAL DIRECTOR SAYS, THERE IS SUGGESTION OF DISSOCIATION OF THE HEAD FROM THE SHAFT ON THE LATERAL VIEW; HOWEVER, I CANNOT SAY FOR SURE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    MANUFACTURING DATE: MARCH 16, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 THE HEAD OF A 6.0MM TITANIUM (TI) MATRIX POLYAXIAL SCREW WAS DISLODGED FROM THE SHAFT OF THE SCREW. ON (B)(6) 2016, THE PATIENT HAD A LUMBAR FUSION AT LEVEL L4-S1 WITH MATRIX DUE TO COMPRESSION. THERE WERE NO REPORTED ISSUES DURING THE INITIAL SURGERY. IT WAS DISCOVERED ON UNKNOWN DATE THAT THE HEAD OF THE LEFT L4 SCREW CAME OFF THE SHAFT. IT IS UNKNOWN HOW THE MALFUNCTION WAS DISCOVERED AND IF THERE WERE ANY ASSOCIATED ADVERSE EVENTS. ON (B)(6) 2016, THE PATIENT UNDERWENT REVISION SURGERY; THE SURGEON REMOVED THREE (3) LOCKING CAPS FROM THREE (3) SCREWS (INCLUDING THE LEFT L4 SCREW) IN ORDER TO REMOVE THE ROD. AFTER REMOVING THE ROD, THE SURGEON WAS ABLE TO REMOVE THE LEFT L4 SCREW AND REUSED THE ROD AND REPLACED THE LEFT L4 SCREW. ALL REMOVALS WERE COMPLETED EASILY WITHOUT INTERVENTION. THREE (3) NEW LOCKING CAPS WERE PUT IN DUE TO THE SURGEON'S PREFERENCE AND THE SURGEON ALSO ADDED A TRANSCONNECTOR. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY OR PATIENT HARM. IT WAS REPORTED THAT THE PATIENT'S OUTCOME/STATUS WAS STABLE. CONCOMITANT DEVICES REPORTED: MATRIX LOCKING CAP WITHOUT SADDLE (PART # 09.632.099, LOT # UNKNOWN, QUANTITY 1), ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR COM- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538093 6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE H063150

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention