BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

    MDR report key: 2873882 · Received December 14, 2012

    Report

    Report Number
    2530088-2012-01080
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED INSTRUMENT WAS SENT TO OUR RELEVANT PM FOR INVESTIGATION; HERE THE RESULT; ONE LOCKING CAP, (B)(4), SHOWS SIGNS OF WEAR AND SMALL BURRS AT THE SADDLE/ROD INTERFACE. THE OTHER FIVE LOCKING CAPS AND THE POLYAXIAL SCREW SHOW NO PARTICULARITIES. ON THE PROVIDED PHOTO OF THE REVISION SURGERY, THE UPPER ROD SURFACE SHOWS SIGNS OF WEAR CAUSED BY FRICTION. THE MARKING COVERS THE COMPLETE CAUDAL END OF THE ROD. AS NO IMMEDIATE POSTOPERATIVE X-RAYS OF THE PRIMARY SURGERY COULD BE MADE AVAILABLE, IT IS VERY DIFFICULT TO ASSESS REASONS FOR THE INCIDENT. A POSSIBLE REASON OF THE FAILURE CAN BE THAT THE ROD IN L4 INITIALLY DID NOT OR ONLY LITTLE PROTRUDE THE SCREW HEAD. FOR CORRECT FUNCTIONALITY OF THE SCREW/ROD FIXATION, A PROTRUSION OF THE ROD OVER THE SCREW HEAD IS REQUIRED. IT IS RECOMMENDED TO CHOOSE THE ROD LENGTH ACCORDINGLY TO ALLOW FOR APP. 5MM OF PROTRUSION OF THE ROD OUT OF THE MOST CRANIAL AND MOST CAUDAL SCREW HEADS. ANOTHER POSSIBLE REASON COULD BE LOOSENING OF THE LOCKING CAP AND SUBSEQUENTLY SLIPPAGE OF THE SCREW ALONG THE ROD. THIS MAY OCCUR IF DURING FINAL TIGHTENING, THE POLYAXIAL SCREW HEAD WAS NOT ALIGNED PERPENDICULARLY TO THE ROD. SUCH A SCREW HEAD CAN POSTOPERATIVELY ALIGN PERPENDICULARLY TO THE ROD BY INDUCTION OF FORCES IN THE CONSTRUCT, E.G. BODY MOVEMENTS OF THE PATIENT. THIS CAN RESULT IN REDUCTION OF THE CLAMPING FORCE BETWEEN LOCKING CAP AND THE ROD, WHICH MIGHT NOT ANYMORE BE SUFFICIENT TO PREVENT THE SCREW HEAD FROM SLIPPING ALONG THE ROD. FURTHER INVESTIGATION SHOWED CONFORMITY OF THE ARTICLES IN QUESTION TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH MATRIX CONSTRUCT, L2-L4 ON AN UNKNOWN DATE. X-RAY, MRI AND CLINICAL ASSESSMENT WAS PERFORMED AND SURGEON NOTED IT LOOKED LIKE THE L4 SCREW HAD MOVED AND THE CAP WAS EITHER UNDONE OR THE HEAD NO LONGER APPEARED TO BE LOCKED. REVISION SURGERY SCHEDULED FOR (B)(6) 2012; SURGEON REMOVED THE PEDICLE SCREW AND REPLACED WITH AN 8MM SCREW AND BONE CEMENT. THIS IS 5 OF 9 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN LOCKING CAP NKB SYNTHES BRANDYWINE 6964655

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, RODS, LOCKING CAPS