BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3071280 · Received April 22, 2013

    Report

    Report Number
    1030489-2013-01188
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF RADIOGRAPHIC IMAGES SHOWS ACDF C5-C6-C7 WITH 6 SCREWS AND ZEPHIR PLATE WITH BIOLOGICAL INTERBODY GRAFTS. INITIAL FILMS SUGGEST ONE OF THE C7 SCREWS WAS PROUD. POST-OP FILMS OF (B)(6) 2013 SHOW BACK OUT OF ONE OF THE C7 SCREWS AND AP SHOWS THAT BOTH LOCKING MECHANISMS ARE NOT DEPLOYED. NO AP VIEW IS AVAILABLE IMMEDIATELY POST-OP TO VERIFY THE PLATE WAS UNLOCKED AT THE CONCLUSION OF SURGERY. THE RESULTS ARE INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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

    ADDITIONAL INFORMATION: A REVIEW OF RADIOGRAPHIC IMAGES SHOWS THAT BASED UPON THE REVIEW OF X-RAYS, ONE SCREW BACKED OUT AS BOTH LOCKING CAPS ARE IN THE UNLOCK POSITION (NOT COVERING THE SCREW HEADS). THE ORIGIN OF THE LOCKING CAPS IN UNLOCK POSITION CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION. THE IMAGES ARE INCONCLUSIVE.

    Description of Event or Problem · 1

    IMPLANT DATE: UNSPECIFIED IN (B)(6) 2013; PT DEMOGRAPHICS: FEMALE, (B)(6). IT WAS REPORTED THAT FOLLOWING ON FROM THE TWO OTHER RECENT ZEPHIR PLATE PIR'S, [REP] WAS INFORMED TODAY THAT A THIRD CASE CAME TO THE ATTENTION OF [DOCTOR] YESTERDAY IN RELATION TO A SCREW BACKING OUT. THE INITIAL REPORT IS THAT THE PATIENT ((B)(6) FEMALE) PRESENT TO [DOCTOR] YESTERDAY (B)(6) 2013. X-RAYS HAVE CONFIRMED THAT THE DISTAL LOWER SCREW HAS PUSHED BACK. THERE IS NO PLAN TO REVISE THE SCREW AT THIS POINT . THE CASE WAS COMPLETED IN (B)(6) (DATE TBC) IN THE [HOSPITAL]. IT WAS A TWO LEVEL ACDF WITH ZEPHIR. THIS IS THE THIRD INCIDENT WITHIN THIS HOSPITAL. THE SURGEON HAS REQUESTED THE HOSPITALS ZEPHIR PLATE SYSTEM TO BE TESTED AS HE BELIEVES THERE MAY BE A BATCH ISSUE. [REP] WILL GATHER AS MUCH INFORMATION AS POSSIBLE IN THE NEXT FEW DAYS. [DOCTOR] HAS BEEN USING ZEPHIR FOR OVER 5 YEARS [REP] BELIEVES AND IS ADAMANT THAT HE LOCKS THE PLATE AFTER THE FINAL XRAY EVERY TIME. X RAYS WILL BE SENT WHEN OBTAINED. QUESTIONS IN PIR_MSG: [REP] HAS ANOTHER PIR FROM [DOCTOR] IN (B)(6) REGARDING THE ZEPHIR PLATE SYSTEM. THIS IS THE THIRD CASE OF A SCREW BACKING OUT AND THE SECOND IN TWO MONTHS. THE SURGEON IS ADAMANT HE IS LOCKING THE PLATE SYSTEM AND IS CURIOUS WHY IT IS ONLY HAPPING TO PATIENTS TREATED IN HIS PRIVATE HOSPITAL. [DOCTOR] IS ONE OF OUR BIGGEST CUSTOMERS AND VERY IMPORTANT TO US. HE HAS REQUESTED TWO ACTIONS. CAN WE CHECK THE PLATES IN THE SET FROM THE BON'S ALREADY SENT BACK CURRENTLY IN QUARANTINE IN CASE THERE MAY BE A BATCH ISSUE. HE BELIEVES THERE IS AN ISSUE BETWEEN THE LOCKING PLATE AND THE PLATE ITSELF AS HE HAS USED THE PLATE FOR AS LONG AS I CAN REMEMBER >5 YEARS WITH PERFECT RESULTS (ABOUT TO PUBLISH A PAPER ON ZEPHIR) . HE HAS REQUESTED AN ENGINEER TO CONTACT HIM TO DISCUSS THE MATTER FURTHER WHEN WE HAVE PROCESSED THE INFORMATION. HISTORY: CERVICAL RADICULOPATHY , INTRACTABLE NECK PAIN INJURY: YES OUTCOME: INTERVENTION REQUIRED: NO, NEED TO RULE OUT A PRODUCT BATCH ISSUE BEFORE PRODUCT CAN BE USED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171927 ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM KWQ MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR