BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 4631877 · Received March 25, 2015

    Report

    Report Number
    2520274-2015-12122
    Event Type
    Injury
    Date Received
    March 25, 2015
    Report Date
    March 12, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    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. DATE OF POSTOPERATIVE CONSTRUCT LOOSENING IS UNKNOWN. UNKNOWN UNIVERSAL SPINE SYSTEM CONSTRUCT WITH POTENTIAL PART NUMBERS AS FOLLOWS: PART # 04.600.016 (6.0MM TI PRECONTOURED ROD 65MM STRAIGHT LENGTH/400MM); QUANTITY: (B)(4); 510K NUMBER: K082572; PRODUCT CODE: NKB; COMMON NAME: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD; ADDITIONAL CODE: MNI , MNH, KWP, KWQ. PART # 498.010 (6.0MM TI COLLAR); QUANTITY: 20; 510K NUMBER: K082572; PRODUCT CODE: NKB; COMMON NAME: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD; ADDITIONAL CODE: MNI, MNH, KWP, KWQ. PART # 498.003 (TI NUT 11MM WIDTH ACROSS FLATS); QUANTITY: (B)(4); 510K: K141897; PRODUCT CODE: KWP; COMMON NAME: APPLIANCE, FIXATION, SPINAL INTERLAMINAL ADDITIONAL CODE: MNH AND MNI. PART # UNK-SCREW(498.XXX-USS SCREWS); QUANTITY: (B)(4); PRODUCT CODE: HWC; COMMON NAME: SCREW, FIXATION, BONE. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 THE PATIENT UNDERWENT AN INITIAL IMPLANT PROCEDURE ON (B)(6) 2014 WHERE A SYNTHES UNIVERSAL SPINE SYSTEM (USS) CONSTRUCT WAS USED TO TREAT DEGENERATIVE SCOLIOSIS. THE CONSTRUCT SPANNED FROM T10-ILIUM. THE PATIENT DEVELOPED HALOS (SCREWS WERE NOT ANCHORED INTO THE BONE ANYMORE) IN 8 OF THE 20 SCREWS FROM THE INITIAL PROCEDURE. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED AN E. COLI INFECTION OF THE SPINAL WOUND SOMETIME POSTOPERATIVE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR WOUND WASHOUTS IN (B)(6) 2014. ADDITIONALLY, THE PATIENT DEVELOPED A FOOT DROP ON THE LEFT SIDE AT AN UNKNOWN TIME. THE SURGEON REPORTED THAT THERE MUST HAVE BEEN SOME COMPRESSION ON THE LEFT NERVE ROOT AT L5-S1 AND WAS NOT SURE IF THIS WOULD SUBSIDE AFTER THE PLANNED REVISION. ON (B)(6) 2015, THE SURGEON REVISED THE USS CONSTRUCT. DURING THE REVISION PROCEDURE, THE SURGEON REPORTED THAT THERE WERE NO SIGNS OF REMAINING INFECTION AND THAT THERE WERE NO ISSUES WITH THE HARDWARE, EXCEPT THAT THE INFECTION HAD EATEN AWAY AT THE BONE AROUND SOME OF THE SCREWS CAUSING THEM TO LOSE PROPER ANCHOR. TWENTY (20) NUTS, TWENTY (20) COLLARS, AND TWO (2) RODS WERE REMOVED DURING THE REVISION PROCEDURE. AFTER THEIR SUCCESSFUL REMOVAL, THE SURGEON CHECKED THE SCREWS TO ENSURE PROPER ANCHORAGE. EIGHT (8) SCREWS WERE DISCOVERED TO BE LOOSE AND WERE, THEREFORE, REPLACED WITH SCREWS OF A DIAMETER SIZE BIGGER. THOSE EIGHT (8) LOOSE SCREWS WERE REPLACED IN LEVELS: L5 (2 SCREWS), S1 (2 SCREWS), ILIUM (2 SCREWS), AND AN UNKNOWN LEVEL (2 SCREWS). THE SURGEON PERFORMED SOME ADDITIONAL BONY DECOMPRESSION AND PLACED NEW RODS, CONNECTING THEM WITH NEW NUTS AND COLLARS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UNKNOWN USS CONSTRUCT T10-ILIUM CONTAINS: 2 RODS, 20 COLLARS, 20 NUTS AND 20 SCREWS. THIS REPORT IS FOR ONE (1) UNKNOWN USS CONSTRUCT ¿ T10-ILIUM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200768 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention