BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK PREVAIL¿ CERVICAL INTERBODY DEVICE

    MDR report key: 3030287 · Received April 2, 2013

    Report

    Report Number
    1030489-2013-00904
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    K073285
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL ASSESSMENT: PROVIDED ARE AN AP AND LATERAL FLOUROSCOPIC INTEROPERATIVE VIEW OF A CERVICAL SPINE. THE SPINE HAS A PREVIOUS ACDF FUSION WITH A DEVICE SPANNING APPROXIMATELY C5 TO C7 WITH ANOTHER DEVICE. ALSO, ANOTHER DEVICE IS ALSO PRESENT POSTERIORLY FROM C5 TO C7. PRESENT ALSO IS AN ADDITIONAL DEVICE AT C7/T1. THIS DEVICE APPEARS TO BE FRACTURED MID SUBSTANCE AS A PORTION IS WITHIN THE DISC SPACE AND A PORTION IS VENTRAL TO IT AND ROTATED. IN ADDITION, THE FIXATION SCREW IS IN RELATIVELY GOOD POSITION WITHIN C7, BUT IS EXTRAOSSEOUS AND ANTERIOR TO T1 IN WHAT APPEARS THE SOFT TISSUE VENTRAL TO THE T1 BODY. IT IS DIFFICULT TO VERIFY THAT THE C7 SCREW IS RETAINED BY THE RETAINING RING. LIMITED FUNCTIONALITY CAN BE EXPECTED FROM THIS CONFIGURATION.

    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 CAGE WAS IMPLANTED AT C7-T1 DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) BELOW A PREVIOUSLY FUSED CORPECTOMY. IT WAS REPORTED THAT THE CAGE HAD BROKEN DOWN THE MIDDLE. THE CAGE WAS NOT REMOVED. ANOTHER SURGERY WAS PLANNED FOR LATER IN THE DAY TO EXTEND THE EXISTING POSTERIOR HARDWARE DOWN FURTHER TO STABILIZE. FRAGMENTS WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134298 PEEK PREVAIL¿ CERVICAL INTERBODY DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MSD DEGGENDORF MFG NA VE70

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other