BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 5538150 · Received March 31, 2016

    Report

    Report Number
    2520274-2016-11898
    Event Type
    Injury
    Date Received
    March 31, 2016
    Report Date
    March 11, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    PMA / PMN Number
    PK142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INITIALS ARE (B)(6). PATIENT WEIGHT IS UNKNOWN. THIS REPORT IS FOR THREE (3) UNKNOWN SCREWS REMOVED FROM: RIGHT T1, LEFT T2, AND RIGHT T2. IT CANNOT BE DETERMINED WHICH LENGTH SCREW WAS REMOVED FROM WHICH LEVEL. POSSIBLE PART INFORMATION INCLUDES: 04.615.130: 4.0MM TI CANCELLOUS POLYAXIAL SCREW 30MM FOR 4.0MM RODS ¿ K142838 ¿ CODES: NKG AND KWP; 04.615.132: 4.0MM TI CANCELLOUS POLYAXIAL SCREW 32MM FOR 4.0MM RODS ¿ K142838 ¿ CODES: NKG AND KWP; 04.615.134: 4.0MM TI CANCELLOUS POLYAXIAL SCREW 34MM FOR 4.0MM RODS ¿ K142838 ¿ CODES: NKG AND KWP; 04.615.136: 4.0MM TI CANCELLOUS POLYAXIAL SCREW 36MM FOR 4.0MM RODS ¿ K142838 ¿ CODES: NKG AND KWP. ADDITIONAL PRODUCT CODES FOR THIS COMPLAINT INCLUDE NKG. WITHOUT VERIFICATION OF THE EXACT PART NUMBERS THAT WERE AFFECTED, THE UDI¿S ARE NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE (FROM C2-T2) WAS CONDUCTED ON AN UNKNOWN DATE IN (B)(6) 2015. AS A NOTE: NOT ALL OF THE ORIGINAL HARDWARE WAS EXPLANTED DURING THE REVISION PROCEDURE ON (B)(6) 2016. SOME OF THE DEVICES REMAIN IN THE PATIENT. THE COMPLAINANT PARTS ARE NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICES WERE RETURNED. WITHOUT LOT NUMBERS, THE DEVICE HISTORY RECORD REVIEWS COULD NOT BE REQUESTED. DEVICE 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 AN ORIGINAL POSTERIOR CERVICAL FUSION PROCEDURE WITH A SYNTHES SYNAPSE 4.0MM ROD SYSTEM FROM C2-T2 ON AN UNKNOWN DAY IN (B)(6) 2015. IT WAS LATER NOTED THAT THE PATIENT HAD NOT HEALED AT THE LOCATION OF CONSTRUCT PLACEMENT. IMAGES TAKEN ON AN UNKNOWN DATE REVEALED THAT THE LOCKING CAPS AT T1 AND T2 HAD BECOME LOOSE AND SEPARATED FROM THE SYNAPSE SCREWS. AS A RESULT, THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2016. DURING THE PROCEDURE, THE SURGEON WAS ABLE TO CONFIRM LOOSENING AND NOTED THAT THE CAPS WERE FLOATING FREE. THE SURGEON THEN DISCOVERED THAT THE LEFT C2 LOCKING CAP HAD ALSO LOOSENED AND SEPARATED FROM THE SCREW AT C2. THE REMAINING LOCKING CAPS WERE REMOVED, BUT NOTED TO BE REASONABLY TIGHT. THE SURGEON ALSO REMOVED THE RODS AND THE 4.0MM SYNAPSE SCREWS AT T1 AND T2. THE LEFT T1 SCREW, WHICH WAS A 4.0MM X 32MM SCREW, HAD BROKEN OFF AT THE HEAD. IT IS UNKNOWN IF THE SCREW HEAD BROKE DURING REMOVAL OR SOMETIME PRIOR TO THE REVISION SURGERY. THE EXPLANTED SYNAPSE SCREWS AT T1 AND T2 WERE REPLACED WITH SYNTHES UNIVERSAL SPINE SYSTEM (USS) DUAL OPENING SCREWS. THE REMAINING SYNAPSE SCREWS WERE LEFT IN THE PATIENT AND NEW SYNAPSE 4.0/6.0MM RODS IMPLANTED. THE RODS WERE CONNECTED TO THE SCREWS AND THE PROCEDURE WAS COMPLETED. NO REPORTED SURGICAL DELAY. THIS REPORT IS FOR THREE (3) UNKNOWN SCREWS REMOVED FROM: RIGHT T1, LEFT T2, AND RIGHT T2. THIS REPORT IS 7 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194668 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.615.527: 4.0MM TI ROD 240MM (X2)