BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 34MM

    MDR report key: 6014012 · Received October 10, 2016

    Report

    Report Number
    2530088-2016-10285
    Event Type
    Injury
    Date Received
    October 10, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKG
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). PATIENT WEIGHT IS UNKNOWN. EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODE: KWP. IMPLANT DATE: UNKNOWN DATE IN (B)(6) 2015. A REVISION PROCEDURE OCCURRED (B)(6) 2016. PART OF THE DEVICE REMAINED IN THE PATIENT; DEVICE NOT CONSIDERED EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART 04.614.034, LOT 6153575: RELEASE TO WAREHOUSE DATE: JUNE 08, 2009. MANUFACTURED AT (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A POSTERIOR CERVICAL FUSION FROM C2-T1 WITH SYNTHES SYNAPSE 3.5 ROD SYSTEM IN (B)(6) 2015 (NO SCREWS AT C7). AT AN UNKNOWN POINT IN TIME, THE PATIENT KYPHOSED BELOW THE POSTERIOR CERVICAL FUSION. ON AN UNKNOWN DATE, THE PATIENT BROKE THE LEFT T1 SCREW ABOUT 10MM BELOW THE LEVEL OF THE HEAD. ON (B)(6) 2016, A REVISION SURGERY WAS PERFORMED. THE SURGEON REMOVED ALL THE SYNAPSE HARDWARE FROM THE (B)(6) 2015 SURGERY. THE SURGEON ATTEMPTED TO REMOVE THE DISTAL SCREW FRAGMENT FROM THE BROKEN LEFT T1 SCREW, BUT WAS NOT ABLE TO REMOVE IT. IT WAS TOO DEEPLY SEATED IN BONE AND WOULD NOT COME OUT. THE SURGEON THEN REPLACED ALL THE REMOVED HARDWARE WITH NEW SYNAPSE 4.0MM ROD SYSTEM HARDWARE. ADDITIONALLY, HE REPLACED ALL THE SYNAPSE SCREWS FROM C2-C6. HE REPLACED THE T1 SCREWS WITH SYNTHES UNIVERSAL SPINE SYSTEM VARIABLE ANGLE SCREWS (USS VAS) 3 SCREWS. THE SURGEON WAS ABLE TO WORK AROUND THE FRAGMENT ON THE LEFT T1. HE ALSO PLACED USS VAS 3 SCREWS AT T3 AND THEN PLACED STANDARD USS SCREWS FROM T4-T10. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY REPORTED. CONCOMITANT DEVICES REPORTED: 3.5 MM TI CANCELLOUS POLYAXIAL SCREW 34MM (PART 04.614.034 (RIGHT), LOT UNKNOWN, QUANTITY 1), 3.5 MM TI CANCELLOUS POLYAXIAL SCREW 14MM (PART 04.614.014, LOT UNKNOWN, QUANTITY: 7), 3.5 MM TI CANCELLOUS POLYAXIAL SCREW 26 MM (PART 04.614.026, LOT UNKNOWN, QUANTITY: 2), TI LOCKING SCREW (PART 04.614.508, LOT UNKNOWN, QUANTITY: 11) AND TI ROD 120MM (PART 498.125, LOT UNKNOWN, QUANTITY: 2). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665580 3.5MM TI CANCELLOUS POLYAXIAL SCREW 34MM ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG SYNTHES BRANDYWINE 6153575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 11 TI LOCKING SCREWS (04.614.508)| 2 TI RODS (498.125)| 7 TI CANCELLOUS POLYAXIAL SCREWS (04.614.014)| TI CANCELLOUS POLYAXIAL SCREW (04.614.034 (RIGHT))| TI CANCELLOUS POLYAXIAL SCREWS (04.614.026)