BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM

    MDR report key: 3930342 · Received July 11, 2014

    Report

    Report Number
    2520274-2014-12468
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    PMA / PMN Number
    PK112068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT IS UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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 ON (B)(6) 2012, THE PATIENT HAD TWO PROCEDURES: FIRST THE LEFT C7-T1 FORAMINOTOMY FOR RESECTION OF SYNOVIAL CYST AND SECOND C3-C4, C5-C6 AND C6-C7 ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH ALLOGRAFT AND PLATING WITH THREE VARIABLE ANGLE ZERO-PROFILE (ZERO-P VA) IMPLANTS. ORIGINALLY, IT WAS REPORTED THAT THE PATIENT HAD TWO LEVELS OF ZERO-P VA IMPLANTED. THE PATIENT CONTACTED THE PHYSICIAN¿S OFFICE IN (B)(6) 2013 TO REPORT ONGOING NECK PAIN, WHICH WAS WORSE AT NIGHT. THE PATIENT WAS ALSO CONCERNED WITH HIS X-RAYS, REPORTING OF A "LOOSE SCREW¿ WHICH WAS OBTAINED FROM HIS PRIMARY CARE PHYSICIAN. THE RADIOLOGY FILMS REVIEWED, IT APPEARED STABLE IN COMPARISON TO THE LAST SET OF POST-OP X-RAYS. THE X-RAYS WITH POSSIBLE LOOSENING AROUND THE SCREW INSERTED AT THE C6 INFERIOR ENDPLATE. THE PATIENT WAS ENCOURAGED TO PARTICIPATE IN POST-OP PHYSICAL THERAPY. PATIENT CONTACTED THE PHYSICIAN¿S OFFICE (B)(6) 2013 TO REPORT ONGOING NECK PAIN AND ONGOING MILD SWALLOWING DIFFICULTIES. PATIENT CONTACTED THE SERVICE AGAIN IN (B)(6) 2013 TO REPORT PROGRESSIVE DIFFICULTY WITH SWALLOWING. THE PATIENT HAD SWALLOW EVALUATION ON (B)(6) 2013 AT (B)(6) MEDICAL CENTER THAT REPORTED POSSIBLE C4 HARDWARE PROTRUSION INTO THE PHARYNX. IT IS UNKNOWN WHEN THE PATIENT HAD C4-C5 SURGERY, HOWEVER, IT IS NOT A SYNTHES IMPLANT. IT WAS ALSO REPORTED THE PATIENT HAD IRRITATION AND DISCOMFORT. ON (B)(6) 2014, SURGICAL REVISION REPLACING IMPLANTS AND SCREWS WAS PERFORMED FOR AN ANTERIOR CERVICAL DISCECTOMY AT C3-C4 AND C5-C6 FOR TWO LEVELS. THE REVISION SURGERY INCLUDED 8 SCREWS, 4 SCREWS PER IMPLANT ¿ TWO IMPLANTS. THE REVISION SURGERY WAS BEING PERFORMED BECAUSE ONE OF THE ORIGINAL SCREWS HAD LOOSENED (C6 INFERIOR ENDPLATE) AND BACKED OUT. DURING REVISION SURGERY ON (B)(6) 2014, THE ANGLED AWL (PART # 03.617.993) BROKE WHILE THE SURGEON WAS ATTEMPTING TO USE THE INSTRUMENT IN THE CORRECT WAY. THE METAL TIP OF THE AWL BROKE OFF AND THE SURGEON WAS ABLE TO EASILY RETRIEVE THE BROKEN PIECE. IT WAS REPORTED THAT THERE WAS NO NEGATIVE EFFECT TO THE PATIENT DUE TO THE INSTRUMENT BREAKING. IN ADDITION, THE ORIGINAL ZERO-P VA IMPLANTS WERE EXPLANTED AND REPLACED WITH AN OLDER STYLE ZERO-P VA IMPLANT AT C3-C4 AND C5-C6. AS PER THE SURGEON¿S OPERATIVE REPORT, "FOLLOWING THIS, WE REMOVED THE CAGE AT C5-C6 WHERE WE NOTICED THAT THE METALLIC PART OF THE GRAFT HAD DETACHED FROM THE PEEK PORTION PROTRUDING INTO THE PRE-CERVICAL TISSUES.¿ THERE WAS A SURGICAL DELAY OF 1 MINUTE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 3 OF 12 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406409 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention