BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    MDR report key: 8191720 · Received December 21, 2018

    Report

    Report Number
    9610612-2018-00579
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 21, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. PMA/510K: K180433. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. (B)(4). INVESTIGATION - NO PRODUCT AT HAND. BATCH HISTORY REVIEW - THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATIONS VALID DURING THE TIME OF PRODUCTION. THERE ARE NO FURTHER COMPLAINTS WITH THIS LOT AND ERROR PATTERN AT HAND. CONCLUSION AND ROOT CAUSE - THE ROOT CAUSE IS MOST PROBABLY USAGE AND/OR PATIENT RELATED. RATIONALE - WITH THE LACK OF INFORMATION AND WITHOUT ANY PRODUCT AVAILABLE FOR ANALYSIS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IN THE INFORMATION THE POSSIBILITY OF BAD BONE STRUCTURE WAS MENTIONED. THIS COULD BE A POSSIBLE ROOT CAUSE FOR THE PROBLEM. ANOTHER POSSIBLE ROOT CAUSE IS A HIGH FORCE USED DURING THE IMPLANTATION OF THE IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS POSTOPERATIVE LOOSENING OF SCREWS. ON (B)(6) 2018, THE PATIENT UNDERWENT INITIAL SPINAL SURGERY AND IMPLANTATION OF ENNOVATE SCREWS, SET SCREWS, A ROD, AND TSPACE PEEK IMPLANTS. IT WAS FELT THAT LOOSENING OF THE SCREWS MAY HAVE OCCURRED DURING APPLICATION WITH THE COMPRESSION FORCEPS DUE TO INSUFFICIENT BONE STRUCTURE. A REVISION WAS PERFORMED FOR LOOSENING ON (B)(6) 2018. THERE WAS REPLACEMENT OF SCREWS IN THE LUMBAR SPINAL BODY 3 AND SACRAL VERTEBRAE; TWO LARGER SCREWS (8.5MM INSTEAD OF 7.5MM) WERE PLACED THE SACRAL VERTEBRAE 1, BILATERAL. THERE WAS REVISION OF SCREWS IN THE LUMBAR SPINAL BODY 4/5, CORPECTOMY OF LUMBAR SPINAL BODY 4/5, VERTEBRAL BODY REPLACEMENT, AND CEMENT AUGMENTATION AT HEIGHT OF LUMBAR SPINAL BODY 3 LEFT SIDE. FURTHER DETAILS WERE NOT PROVIDED. THIS REPORT ADDRESSES THE ENNOVATE POLYAXIAL SCREW (1 OF 1), 6.5MM, FENESTRATED. ASSOCIATED MEDWATCHES: 9610612-2018-00578; 9610612-2018-00616; 9610612-2018-00580; 9610612-2018-00617; 9610612-2018-00618.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028932 ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR. POSTERIOR STABILISATION NKB AESCULAP AG SY834TS 52370951

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention CURVED ROD REF. SY938TS, 52370795| PEEK IMPLANT REF. SN338P, 52322024| PEEK IMPLANT REF. SN340P, 52229086| SET SCREW REF. SY001TS, 52374779| SET SCREW REF. SY001TS, 52382963| SET SCREW REF. SY001TS, 52407323