BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI QUICK LOCK CANCELLOUSSCREW SELF-TAPPING 14MM

    MDR report key: 3940780 · Received July 17, 2014

    Report

    Report Number
    2520274-2014-01014
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    K000536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 1 UNKNOWN SCREW. IT IS UNKNOWN WHETHER THE SCREW WAS EXPLANTED. REPORTABLE MALFUNCTION AND SERIOUS INJURY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (X-RAYS, LATE (B)(6) 2013) TO MRI, (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT'S (B)(6). (B)(6) AT TIME OF REVISION SURGERY. THIS REPORT IS FOR TWO UNKNOWN SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A C5-C6 ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE ON (B)(6) 2013, WITH A CAGE, PLATE AND SCREWS, A DRILL BIT WAS USED THAT DID NOT HAVE A STOP TO IT. IT WAS NOT UNTIL THE SURGEON WAS USING THE INSTRUMENTS AND MAKING HIS HOLES FOR THE SCREWS, THAT HE NOTICED THAT THERE WAS NO STOP. WITHOUT THE DEPTH STOP, IT IS UNDETERMINED HOW DEEP THE DRILL WENT. THE SURGEON COMPLETED THE SURGERY AS PLANNED WITH THE CORRECT DRILL BIT. THE PATIENT IS DOING WELL AND WAS DISCHARGED. IT WAS LATER REPORTED THAT THE SYNAPSE DRILL BIT WAS ACCIDENTALLY PLACED IN THE ACDF GRAPHIC CASE. THE SYNAPSE DRILL BIT HAD A STOP BUT WAS DESIGNED TO WORK WITH A DIFFERENT DRILL GUIDE THAN THE ONE THAT WAS UTILIZED. IT WAS LATER REPORTED BY THE PATIENT'S COUNSEL THAT WHEN THE SURGEON USED THE UNGUARDED DRILL BIT, THE SURGEON PIERCED THROUGH THE ANTERIOR RIGHT SIDE OF THE PATIENT'S C5 VERTEBRAE AND STRUCK HER SPINAL CORD. IT WAS ALSO REPORTED THAT THE SURGEON INSERTED A STABILIZING PLATE THAT WAS TOO BIG AND THE SCREWS DUG INTO THE PATIENT'S C6-C7 DISC, ULTIMATELY NECESSITATING A SECOND CORRECTIVE SURGERY ON (B)(6) 2014. IT IS UNKNOWN WHETHER THE HARDWARE WAS EXPLANTED. THIS REPORT IS FOR ONE UNKNOWN SCREW. THIS IS 3 OF 3 REPORTS FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. DURING THE ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE ON (B)(6) 2013, AT LEVEL C5-C6, THE SURGEON USED AN UNGUARDED DRILL BIT WHICH PIERCED THROUGH THE ANTERIOR RIGHT SIDE OF THE PATIENT'S C5 VERTEBRAE AND STRUCK HER SPINAL CORD WHICH ALSO PRODUCED A DURAL LEAK. THIS IS 3 OF 9 REPORTS FOR COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AT C5-6 ON (B)(6) 2014 DUE TO CHRONIC PAIN, CERVICAL SPONDYLOSIS WITH MYELOPATHY, MALPOSITIONED PLATE AND INFERIOR SCREWS, AND A POSSIBLE NON-UNION. THE POST-OPERATIVE X-RAYS REVEALED THAT THE C6 SCREWS, WHICH HAD BEEN PARTIALLY IN THE BODY OF C6 AND PARTIALLY IN THE BODY OF C6-7, HAD MIGRATED INTO THE C6-7 CARTILAGE DISK ENTIRELY. AS THE CAGE SETTLED IN, THE PLATE EXTENDED ITSELF DOWN OVER THE C6-7 DISC LEVEL. IT WAS ALSO NOTED THAT THE UPPER SCREWS COULD BE REMOVED WITH ONLY MODERATE DIFFICULTY DUE TO BREAKAGE OF ONE OF THE FOUR PARTS OF THE RIGHT CRUCIATE SCREW. THE TIMING OF THE SCREW BREAKAGE IS UNKNOWN. THE SURGEON DECIDED TO REMOVE THE PLATE AND SCREWS AND LEAVE THE CAGE IMPLANTED DUE TO CONCERN THAT IT MIGHT BE DAMAGING TO THE DISK OVERTIME, WITH TOGGLING AS THE PATIENT MOVES, THIS COULD LEAD TO ACCELERATED DEGENERATION OF THE DISC AND POTENTIALLY AN EARLY NEED FOR FUSION AT THE C6-7 LEVEL. THIS REPORT IS FOR TWO UNKNOWN SCREWS. THIS IS 3 OF 4 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418654 4.0MM TI QUICK LOCK CANCELLOUSSCREW SELF-TAPPING 14MM KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention