BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR® ANTERIOR CERVICAL SYSTEM

    MDR report key: 4555360 · Received February 27, 2015

    Report

    Report Number
    1030489-2015-00389
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    January 30, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: CT SCAN SAGITTAL VIEWS SHOW AN ACDF FROM C4 TO C6. THE C4 SCREWS ARE JUST BELOW THE SUPERIOR END PLATE OF C4 AND THREATEN THE C3/4 DISC. THERE HAS BEEN A COMPLETE CORPECTOMY OF C5 AND THE MAJORITY OF C4. THE LAST SAGITTAL IMAGE SHOWS ONE OF THE C6 SCREWS BACKED OUT APPROXIMATELY 80% OF ITS LENGTH OR ABOUT 12 MM. SEVERE DEGENERATIVE ARTHRITIS OF THE DISCS ARE NOTED AT T3/4 AND T2/3 AXIAL VIEWS SHOW THE PLATE HAS LIFTED OFF OF THE ANTERIOR SURFACE OF C6. IN ADDITION THE SCREW ON THE RIGHT SIDE HAS BACKED OUT NEARLY ALL THE WAY. ITS TIP IS STILL IN CONTACT WITH THE PLATE. LATERAL X-RAYS SHOW THE PLATE IN PLACE WITH THE INFERIOR SCREWS ADJUSTED DOWNWARD PENETRATING THE SUPERIOR ENDPLATE OF C6. THIS PUTS CONSIDERABLE PRESSURE ON THE ANTERIOR INFERIOR LIP OF C6. ALSO THE SCREWS APPEAR TO BE OVERLY ANGULATED IN RELATION TO THE PLATE, CREATING STRESS ON THE LOCKING MECHANISM. AP FILM SHOWS THE PLATE IN MIDLINE SPANNING C4 TO C6.

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8792113, 510K # K994239 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS : VISUAL AND OPTICAL INSPECTION OF THE TOP (ANTERIOR) FACE OF THE SCREW HEAD IDENTIFIED WITNESS MARKS AND MATERIAL DEFORMATION. SOME EVIDENCE OF SPIRAL WITNESS MARKS JUST BELOW THE HEAD ARE NOTED. INSPECTION OF THE BONE SCREW HEAD OUTER DIAMETER AND MAJOR THREAD DIAMETER FOUND BOTH DIMENSIONS TO BE WITHIN PRINT TOLERANCE. CONCLUSION: AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT COMPONENTS. (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT UNSPECIFIED SPINAL PROCEDURE AT THE APPROXIMATE LEVELS OF C5-C7 ON (B)(6) 2014. ON (B)(6) 2015, THE PATIENT PRESENTED WITH SYMPTOMS OF DISCOMFORT AND AN X-RAY REVEALED THAT ONE OF THE 4 SCREWS USED WAS BACKED OUT COMPLETELY. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER FACILITY FOR FURTHER INSPECTION SINCE DAMAGE OF ESOPHAGUS AND/OR RESPIRATORY TRACT WAS SUSPECTED. REVISION WAS PERFORMED AT MIDNIGHT. DURING THE REVISION, THE LOCKING MECHANISM OF THE PLATE LOCATED ON THE BACKED OUT SCREW WAS FOUND TO BE BROKEN AND BOTH THE FRAGMENT OF THE LOCKING MECHANISM AND THE SCREW WERE MISSING. DAMAGE OF ESOPHAGUS WAS OBSERVED. THE BACKED OUT SCREW WAS FOUND IN ESOPHAGUS AND ABLE TO BE RETRIEVED. HOWEVER, THE FRAGMENT OF THE LOCKING MECHANISM COULD NOT BE FOUND. THE DAMAGE WAS THEN SUTURED WITH SEVEN STICHES. THE PLATE AND OTHER SCREWS WERE ALSO REMOVED. NO RESPIRATORY TRACT DAMAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138398 ZEPHIR® ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA H5114639

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention CERVICAL PLATE, SCREWS