BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 14MM

    MDR report key: 4587211 · Received March 10, 2015

    Report

    Report Number
    2520274-2015-11661
    Event Type
    Injury
    Date Received
    March 10, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    PK071667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PRODUCT INVESTIGATION SUMMARY: THE PLATE WAS RETURNED WITH A BROKEN WISHBONE CLIP IN ONE OF THE HOLES. ALL OF THE RETURNED SCREWS WERE INSERTED INTO THE HOLE WITH THE BROKEN CLIP AND THEY WERE UNABLE TO BE LOCKED. THE COMPLAINT CONDITION OF SCREW BACK OUT WAS ABLE TO BE REPLICATED. THE EXACT ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. THE TWO LEVEL VECTRA-T PLATE (PART 450.564, LOT 7723859) WAS RETURNED WITH SCRATCHES THROUGHOUT THE TOP OF THE PLATE AND WITH A BROKEN WISHBONE CLIP. THE VARIABLE ANGLE SCREWS (QUANTITY OF 6) WERE RETURNED NICKED AND WITH THE ANODIZATION WORN OFF IN SPOTS. THE VECTRA-T PLATE IS DESIGNED WITH ELGILOY WISHBONE CLIPS TO LOCK THE SCREWS TO THE PLATE AND FOR THE CARRIAGE TO TRANSLATE TO ACCOMMODATE BONE GRAFT RESORPTION. THE ASSOCIATED PRODUCT DRAWINGS WERE REVIEWED DURING THE EVALUATION. THE SCREW WAS LIKELY ABLE TO BACK OUT DUE TO THE BROKEN WISHBONE CLIP. THE CLIP WAS ABLE TO BE REMOVED FROM THE PLATE AND IT COULD BE SEEN THAT THE CLIP BROKE ON ONE SIDE. THE OTHER PLATE HOLES WERE INSPECTED AND THE CLIPS ARE INTACT. THE CLIP COULD HAVE BEEN DAMAGED OR BROKEN INTRA-OPERATIVELY IF THE AWL WAS INSERTED OR REMOVED AT AN ANGLE. OVER INSERTING THE DTS GUIDE OR INSERTING THE VARIABLE ANGLE SCREWS OUTSIDE OF THE 28 DEGREE RANGE COULD HAVE ALSO BROKEN THE CLIP. THE EXACT ROOT CAUSE IS INDETERMINATE. SURGEON REQUESTED THE MATERIAL COMPOSITION OF THE PLATE DUE TO A POSSIBLE ALLERGIC REACTION FROM THE PATIENT. PER DRAWINGS, THE MATERIAL OF THE BASE PLATE CARRIAGE IS (B)(4). THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. HOLE PREPARATION OR SCREW INSERTION COULD HAVE BROKEN THE CLIPS. THE CLIP MAY HAVE ALSO FAILED IN FATIGUE ALTHOUGH IT IS UNKNOWN HOW LONG THE PLATE HAD BEEN IMPLANTED. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. NO DESIGN ISSUES WERE NOTED. DEVICE IS 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.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSISIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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. 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 THE SCREW AT LEFT C7 WAS LOOSENING AND BACKING OUT POST OPERATIVELY. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TI VECTRA-T PLATE (PART # 450.564) AT LEVELS C5-C7 ON AN UNKNOWN DATE DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY. ON AND UNKNOWN DATE, IT WAS DISCOVERED THAT THE PATIENT HAD ADJACENT LEVEL DISC DISEASE AT C4-C5. A REVISION SURGERY WAS SCHEDULED TO HAVE THE VECTRA T-PLATE REMOVED WITH A GOAL OF IMPLANTING NEW HARDWARE. IT WAS REPORTED THAT THE SCHEDULED EXPLANT TOOK PLACE ON (B)(6) 2015 TO REMOVE THE 34MM VECTRA T-PLATE HARDWARE AT C5-C7. UPON INSPECTION, DURING THE REVISION, IT WAS IDENTIFIED RADIO GRAPHICALLY THAT THE C7 LEFT SCREW WAS LOOSENING AND BACKING OUT. WHILE THE SURGEON WAS REMOVING THE HARDWARE HE DISCOVERED SOME TYPE OF INFECTION. THE SURGEON REQUESTED CULTURES ON THE INFECTED AREA AND THEY CAME BACK NEGATIVE. THE SURGEON IS REQUESTING MATERIALS TESTING ON THE PLATE FOR A POSSIBLE ALLERGIC REACTION TO THE PATIENT. DUE TO THE INFECTION, NO NEW HARDWARE WAS IMPLANTED DURING THE REVISION. NO SURGICAL TIME DELAY WAS REPORTED. THE PATIENT IS CURRENTLY UNDERGOING IV ANTIBIOTICS. THIS IS REPORT 4 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165776 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 14MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention