BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRAGE,POLYAXIAL SCREW 5.0X30MM

    MDR report key: 4930965 · Received July 20, 2015

    Report

    Report Number
    2184052-2015-00073
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K133556
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED DEVICE CONCLUDED THAT THERE IS NO EVIDENCE OF A PRODUCT DEFECT, AND OPERATIONAL CONTEXT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER AND LOT NUMBER WERE CORRECTED AS ALL FOUR INITIAL MDR'S WERE SUBMITTED FOR THE SAME PART NUMBER (07.01728.001 LOT 62874572). PRODUCT RECEIPT DATE WAS ADDED. OFFICE CONTACT NAME AND E-MAIL WAS UPDATED. WAS UPDATED TO REFLECT THE DATE OF PRODUCT IDENTITY. SUPPLEMENTAL REPORT TWO OF FOUR FOR THE SAME EVENT, REFERENCE 2184052-2015-00072-1, 2184052-2015-00074-1 AND 2184052-2015-00075-1. THIS REPORT WAS INITIALLY SUBMITTED AS 0002184052-2015-00073-1 ON 3/31/2016 TO FDA. FDA SENT NOTIFICATION ON 5/8/2017 THAT THIS INITIAL FILE WAS DELETED FROM THE IMAGE200+ APPLICATION BECAUSE OF THE THREE LEADING ZEROS AT THE BEGINNING OF THE REPORT NUMBER AND REQUESTED THE REPORT BE SENT WITHOUT THE LEADING ZEROS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE SCREWS DUE TO CLOSURE TOP LOOSENING FROM THE RODS.

    Description of Event or Problem · 1

    OPERATIVE RECORDS WERE RECEIVED ON MARCH 7, 2016. "PREOPERATIVE DIAGNOSES: C7/T1, T1/T2 INSTRUMENTATION FAILURE STATUS POST C2-T2 POSTERIOR CERVICAL DECOMPRESSION AND FUSION FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. PROCEDURE:1. EXPLORATION OF PRIOR FUSION, REMOVAL OF PRIOR POSTERIOR SEGMENTAL INSTRUMENTATION, PLACEMENT OF NEW SEGMENTAL INSTRUMENTATION C6-T2, REVISION POSTEROLATERAL FUSION C6-T2, PLACEMENT OF DEMINERALIZED BONE MATRIX. FINDINGS: THERE WAS FAILURE OF THE SET SCREWS AT THE T1 AND T2 LEVELS BILATERALLY WITH SIGNIFICANT INSTABILITY AT THE CERVICOTHORACIC JUNCTION. INDICATIONS: THIS IS A (B)(6) FEMALE WHO IS APPROXIMATELY 2 MONTHS STATUS POST A C2-T2 DECOMPRESSION AND FUSION FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT WITH SEVERE CERVICAL STENOSIS. SHE INITIALLY DID VERY WELL FROM THAT OPERATION AND THEN PRESENTED WITH INCREASED NECK PAIN. IMAGING REVEALED DISLOCATION OF THE ROD FROM THE INFERIOR MOST SCREWS OF THE CERVICOTHORACIC JUNCTION. HER PAIN PROGRESSED AND I SAW HER IN THE OFFICE TODAY. HER PAIN HAD DRAMATICALLY INCREASED AND SHE FELT THAT SHE COULD NOT HOLD HER HEAD UPRIGHT. AS SUCH, I FELT THAT SHE WOULD BENEFIT FROM AN URGENT REVISION OF HER INFERIOR ASPECT OF HER CONSTRUCT. THE RISKS AND BENEFITS WERE DISCUSSED WITH HER IN DETAIL AND SHE WAS ADMITTED DIRECTLY FROM THE OFFICE FOR URGENT SURGICAL TREATMENT. DESCRIPTION OF PROCEDURE: (RELATED TO REMOVAL OF DEVICES) "THE PRIOR FUSION WAS CAREFULLY EXPLORED. THERE WAS EVIDENCE OF INSTABILITY AT C7/T1 AND T1/T2 WITH DISLOCATION OF THE ROD FROM THE SCREWS AT T1/T2." I STARTED BY CUTTING THE PRIOR RODS AT APPROXIMATELY THE C7 LEVEL. I THEN USED THE ZIMMER REMOVAL TOOLS TO REMOVE THE SCREWS AT T1 AND T2 BILATERALLY. THOSE SCREWS WERE WELL FIXATED AND I PROBED THE TRACTS. THERE WAS NO EVIDENCE OF LOOSENING OF THOSE SCREWS OR FRACTURES." NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469614 VIRAGE,POLYAXIAL SCREW 5.0X30MM SCREW KWP ZIMMER SPINE, INC. 07.01728.001 62703319

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention