BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING SCREW

    MDR report key: 7046453 · Received November 20, 2017

    Report

    Report Number
    1719045-2017-11201
    Event Type
    Injury
    Date Received
    November 20, 2017
    Report Date
    May 12, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKG
    UDI-DI
    10705034739229
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICES. TWO TI LOCKING SCREWS WERE RETURNED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THE THREADS WHICH INTERACT WITH THE POLYAXIAL HEAD WERE FOUND TO BE WELL DEFINED AND WITHOUT DEFORMATION. ADDITIONALLY AVAILABLE X-RAYS WERE REVIEWED WHERE THE COMPLAINT CONDITION WAS UNABLE TO BE CONFIRMED. AS NO ISSUES WERE IDENTIFIED WITH THE DEVICES/X-RAYS, THE COMPLAINT IS UNABLE TO BE REPLICATED AND IS UNCONFIRMED. THE FOLLOWING IMPLANTS WERE ADDITIONALLY RETURNED WITHOUT ALLEGATION: 04.615.526 LOT 9897197, 04.615.526 LOT L146883, 04.615.232 LOT H15388, 04.615.230 LOT H226907 . THE DEVICES WERE EXAMINED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED OTHER THAN MINOR SURFACE FINISH WEAR WHICH CAN BE ATTRIBUTED TO IMPLANTATION AND EXPLANTATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DRAWING REVIEW, COMPLAINT HISTORY REVIEW AND DEVICE HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE TI LOCKING SCREW (04.614.508) IS A COMPONENT OF THE SYNAPSE SYSTEM WHICH PROVIDES POSTERIOR STABILIZATION TO THE OCCIPITO-CERVICO-THORACIC SPINE. THE SYSTEM CONTAINS TOP LOADING POLYAXIAL SCREWS AND HOOKS WHICH INTERACT WHICH FORM A CONSTRUCT WHEN PAIRED WITH 4.0MM TITANIUM RODS AND LOCKING SCREWS. FOLLOWING POLYAXIAL SCREW AND/OR HOOK PLACEMENT AND ROD INSERTION, THE TI LOCKING SCREWS CAN BE INSERTED AND FINIAL TIGHTENED USING A 2.0NM TORQUE LIMITING HANDLE (03.614.035). THE RETURNED TI LOCKING SCREWS WERE EXAMINED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THE THREADS WHICH INTERACT WITH THE POLYAXIAL HEAD WERE FOUND TO BE WELL DEFINED AND WITHOUT DEFORMATION. ADDITIONALLY AVAILABLE X-RAYS WERE REVIEWED WHERE THE COMPLAINT CONDITION WAS UNABLE TO BE CONFIRMED. AS NO ISSUES WERE IDENTIFIED WITH THE DEVICES/X-RAYS, THE COMPLAINT IS UNABLE TO BE REPLICATED AND IS UNCONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED DEVICES WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS APPLICABLE AS THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL REVIEW, WAS PERFORMED FOR THE RETURNED IMPLANT¿S LOT NUMBER AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THIS COMPLAINT CONDITION IS ADEQUATELY COVERED BY THE RISK ASSESSMENT. 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

    (B)(6). DATE OF DEVICE LOOSENING IS NOT KNOWN. ADDITIONAL PRODUCT CODES: KWP, MNH, MNI . RETURNED TO MANUFACTURER A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.614.508, LOT# H185684. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: OCT 19, 2016. COMPONENT LOT H040185, PART BK100018 BLANK, 9.5MM TI W/T15. FINISHED LOT MACHINED AND CERTIFIED BY GENERAL MACHINE INC. THE PRODUCT HAS BEEN CERTIFIED AND ACCEPTABLE PER REQUIREMENTS. COMPONENT LOT H040185, PART NUMBER BK100018, DATE OF MANUFACTURE: JULY 27, 2016. THE COMPONENT WAS MACHINED AND CERTIFIED BY UNIVERSAL PUNCH. THE PRODUCT HAS BEEN CERTIFIED AND ACCEPTABLE PER REQUIREMENTS. RAW MATERIAL LOT 7009843, PART 21039, TIALNBRI9.50. MATERIAL CERTIFIED BY (B)(4) AND ALL REQUIREMENTS WERE MET. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS 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 THAT A PATIENT UNDERWENT A C2-T2 POSTERIOR CERVICAL FUSION PROCEDURE USING THE SYNTHES 4.0MM SYNAPSE SYSTEM ON (B)(6) 2017. POSTOPERATIVELY, IT WAS IDENTIFIED THAT A TOTAL OF THREE (3) SYNTHES TITANIUM (TI) LOCKING SCREWS HAD LOOSENED, AND TWO (2) OF THE SCREWS WERE FREE FLOATING ABOVE THE HEAD OF THE IMPLANTED SYNAPSE 4.0MM SCREWS. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE COMPLAINED DEVICES ALONG WITH THE REMAINING IMPLANTED DEVICES WERE REMOVED EASILY AND THE SURGEON REVISED THE PATIENT USING THE SYNAPSE AND SYNTHES UNIVERSAL SPINE SYSTEM (USS) SCREWS AND RODS. THE CONSTRUCT WAS EXTENDED TO COVER C2-T4. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE STABLE. CONCOMITANT DEVICES REPORTED: SYNAPSE 4.0MM SCREWS (PART 04.615.232, LOT NUMBER UNKNOWN, QUANTITY 2); SYNAPSE 4.0MM RODS (PART 04.615.526, LOT NUMBER UNKNOWN, QUANTITY 2) THIS REPORT IS FOR ONE (1) TITANIUM LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825220 TI LOCKING SCREW ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG SYNTHES MONUMENT 04.614.508 H185684 10705034739229

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention ROD (04.615.526, LOT UNKNOWN, QTY 2)| SCREW (04.615.232, LOT UNKNOWN, QTY 2)