BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 6814549 · Received August 23, 2017

    Report

    Report Number
    3000270450-2017-10305
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 2, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE CODES MNH, MNI, KWQ, KWP. UDI: (B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER PHONE NUMBER IS NOT AVAILABLE FOR REPORTING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 04.632.740S, LOT # L021458: PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY. 04.632.740S - L021458: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 14.JUN.2016, EXPIRY DATE: 01.JUN.2026: NO NON CONFORMANCE REPORTS (NCRS) 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. FOR THE NON-STERILE ARTICLE AND LOT COMBINATION 04.632.740 - H084314: MANUFACTURE LOCATION: (B)(4), MANUFACTURE DATE: 18-APR-2016: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM, PART NUMBER 04.632.740S, LOT NUMBER L021458). FOLLOWING DEVICE WAS RETURNED FOR CQ INVESTIGATION; PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM P/N 04.632.740S, LOT# L021458. CUSTOMER QUALITY (CQ) ENGINEERING INVESTIGATION: THE COMPLAINT CONDITION IS CONFIRMED. THE COMPLAINT SAYS THAT THE POLYAXIAL HEAD DROPPED OFF DURING ITS REMOVAL ATTEMPT. IT WAS OBSERVED WITH THE PEDICAL SCREW RETURNED AT CQ LOCATION THAT THE POLYAXIAL HEAD HAD SHIFTED DOWNWARDS FROM IT'S ORIGINAL POSITION. IDEALLY, THE COLLET SHOULD BE HELD WITHIN THE BASE OF THE POLYAXIAL HEAD AND IS MEANT TO MINIMIZE FRICTION BETWEEN THE POLYAXIAL HEAD AND THE SCREW. NO SCRATCH MARKS WERE OBSERVED ON THE POLYAXIAL HEAD. THE SCREW SHAFT AND STARDRIVE RECESS SHOW MINOR WEAR WHICH IS IN LINE WITH IMPLANTATION-EXPLANTATION ATTEMPT OF THE IMPLANT. THE OVERALL BALANCE OF THE DEVICE LOOKS IN A GOOD AND FUNCTIONAL CONDITION WITH MINOR WEAR WHICH DOES NOT IMPACT FUNCTIONALITY. THE SCREW SHAFT AND STARDRIVE RECESS SHOW MINOR WEAR WHICH IS IN LINE WITH IMPLANTATION-EXPLANTATION ATTEMPT OF THE IMPLANT. THE COMPLAINT CONDITION COULD NOT BE REPLICATED. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. VISUAL INSPECTION: THE COMPLAINT CONDITION IS CONFIRMED. THE COMPLAINT SAYS THAT THE POLYAXIAL HEAD DROPPED OFF DURING ITS REMOVAL ATTEMPT. IT WAS OBSERVED WITH THE PEDICAL SCREW RETURNED AT CQ LOCATION THAT THE POLYAXIAL HEAD HAD SHIFTED DOWNWARDS FROM IT'S ORIGINAL POSITION. THE COLLET SHOULD BE HELD WITHIN THE BASE OF THE POLYAXIAL HEAD AND IS MEANT TO MINIMIZE FRICTION BETWEEN THE POLYAXIAL HEAD AND THE SCREW. NO SCRATCH MARKS WERE OBSERVED ON THE POLYAXIAL HEAD. THE SCREW SHAFT AND STARDRIVE RECESS SHOW MINOR WEAR WHICH IS IN LINE WITH IMPLANTATION-EXPLANTATION ATTEMPT OF THE IMPLANT. THE OVERALL BALANCE OF THE DEVICE LOOKS IN A GOOD AND FUNCTIONAL CONDITION WITH MINOR WEAR WHICH DOES NOT IMPACT FUNCTIONALITY. DRAWING REVIEW: 7.0MM MATRIX TI SCREW DRAWING 04_632_725 (MFG & CURRENT) WAS REVIEWED. IT WAS OBSERVED THAT THE RETURNED MATRIX SCREW WAS MANUFACTURED PER THE DRAWING. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. IT WAS OBSERVED WITH THE PEDICAL SCREW RETURNED AT CQ LOCATION THAT THE POLYAXIAL HEAD HAD SHIFTED DOWNWARDS FROM IT'S ORIGINAL POSITION. THE SURGEON FAILING TO INSERT THE SCREW IN THE RIGHT POSITION IS MOST PROBABLY DUE TO IMPROPER TECHNIQUE. THE PEDICAL SCREW UNDERWENT INSERTION AND EXTRACTION PROCESSES DURING THE SAME SURGERY. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS APPLIED ON THE SCREW, ESPECIALLY ON THE POLYAXIAL HEAD, DURING EXTRACTION WHICH MADE IT TO SHIFT DOWNWARDS/DROP-OFF. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017; THE SURGERY FOR LUMBAR DEGENERATIVE DISEASE WAS PERFORMED USING THE MATRIX 5.5 SYSTEM TO TREAT THE L5 ¿ S LEVELS. DURING THE SURGERY, THE SURGEON FAILED TO INSERT THE SCREW IN A RIGHT POSITION. WHEN HE TRIED TO TAKE IT OUT USING A DRIVER, THE POLYAXIAL HEAD WAS DROPPED OFF. SURGEON USED ANOTHER SCREW TO COMPLETE THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. CONCOMITANT DEVICE REPORTED: DRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 7.0MM TI MATRIX POLYAXIAL SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593024 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES SELZACH L021458

    Patients

    Seq Age Sex Outcome Treatment
    1