BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR® ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3099318 · Received May 8, 2013

    Report

    Report Number
    1030489-2013-01574
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: WITNESS MARKS AND PLASTIC DEFORMATION NOTED ON DRIVER INTERFACE FEATURES. VISUAL AND OPTICAL INSPECTION OF THE TOP (ANTERIOR) FACE OF THE SCREW HEADS IDENTIFIED PLASTIC DEFORMATION AND WITNESS MARKS, WITH ADDITIONAL WITNESS MARKS JUST BELOW THE HEAD. DIMENSIONAL INSPECTION OF RELEVANT SPECIFICATIONS CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. AFTER VISUAL OPTICAL, AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT COMPONENTS; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. RADIOLOGY FILMS INTERPRETATION: "MULTIPLE X-RAYS OF COMPLEX CERVICAL SURGERY. POST-OPERATIVELY POSTERIOR SURGERY HAS BEEN PERFORMED, POSSIBLE LAMINOPLASTY. ANTERIOR PLATING EXTENDING C3-C6 WITH SCREWS TOO SHORT AND PLACED TOO NEAR INFERIOR C6 ENDPLATE. WITH COLLAPSE OF C3-C6 SCREWS PUSHED OUT INTO C6/7 DISC, THEN SCREWS BACKED OUT."

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 8792113 AND 8799157 AND 510K # K994239 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G8792113 / LOT: H10K0320 (X3) PART: G8792113 / LOT: H10L1395 PART: G8799157 / LOT: W06F3952. ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AFTER THE RIGHT C6 SCREW OF A CERVICAL PLATE CONSTRUCT WAS CONFIRMED TO BE "BACKED OUT ABOUT 5MM". THE PHYSICIAN REPORTED THAT THE SCREW WAS LOCKED WITH THE PLATE'S LOCKING CAP IN THE INITIAL PROCEDURE AND IT WAS FOUND DURING THE REVISION THAT THE LOCKING MECHANISM ON THE PLATE WAS BROKEN. ACCORDING TO THE REPORT, THE PATIENT WAS ASYMPTOMATIC AND BONE FUSION WAS COMPLETE PRIOR TO THE REVISION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200799 ZEPHIR® ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR CERVICAL PLATE, SELF TAPPING CERVICAL SCREWS