BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE

    MDR report key: 3242217 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04453
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING EVALUATION WAS PERFORMED FOR A ZERO P PLATE, PART NUMBER 04.617.127S, LOT NUMBER 8324419. NO VISUAL DEFECTS WERE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. THE PLATE HOLES A AND D WERE DAMAGED POST PRODUCTION (NOT MANUFACTURING RELATED). ALL RELEVANT MEASURABLE PRODUCT FEATURES MET SPECIFICATION WITH THE EXCEPTION OF FEATURE 4EXT AND 5-6 FOR HOLES A AND D WHICH WERE DAMAGED (POST PRODUCTION); CONSIDERING THAT THESE FEATURES WERE MANUFACTURED WITH THE SAME PARAMETERS AND TOOLS OF HOLES B AND C WHICH RESULTED CONFORMING, THE CONCLUSION OF THE PRODUCT INVESTIGATION WAS THAT THE COMPLAINED PART WAS CONFORMING FROM A MANUFACTURING PERSPECTIVE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. EXPIRATION DATE NOT FOUND IN SYSTEM.

    Additional Manufacturer Narrative · 1

    THE ZERO-P INSTRUMENT AND IMPLANT CERVICAL SYSTEM INCLUDES A LARGE FAMILY OF LORDOTIC, CONVEX, AND PARALLEL IMPLANTS WITH HEIGHTS FROM 5MM TO 12MM. THE SYSTEM ALSO INCLUDES THREE LENGTHS OF LOCKING SCREWS (04.617.812, 04.617.814, AND 04.617.816). THE ASSOCIATED DRAWINGS WERE REVIEWED WHICH DETAIL THE APPROPRIATE DIMENSIONS, MATERIALS, AND FINISHING PROCESSES FOR A SUCCESSFUL LOCKING SCREW/PLATE CONNECTION. THE EVIDENCE PROVIDED BY THE RETURNED IMPLANTS SUGGESTS THAT TWO SCREWS WERE NOT COMPLETELY LOCKED TO THE CAUDAL HOLES. SINCE THE COMPLAINT DESCRIPTION DOES NOT SPECIFY THE SCREW BACK OUT LOCATION, THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A ZERO-P REVISION. A PATIENT WAS TREATED WITH ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT LEVELS C5-C6, C6-C7 ON (B)(6) 2013. THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN. X-RAYS WERE TAKEN ON AN UNKNOWN DATE AND SHOWED TWO SCREWS HAD BACKED OUT OF ZERO-P PLATE AT C6-C7. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013; THE SURGEON REMOVED FOUR SCREWS AND THE PLATE AT C6-C7. THE PLATE AND SCREWS AT C5-C6 REMAINED INTACT AND IMPLANTED. THE PATIENT WAS THEN REVISED TO A BONE FILLER AND A DEPUY PLATE AND SCREWS AT C6-C7. THE PATIENT REPORTEDLY IS RECOVERING WELL. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344326 ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE OVE SYNTHES GMBH 8324419

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention