BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P LORDOTIC H6 PEEK

    MDR report key: 3173074 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03413
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    March 1, 2012
    Report Date
    June 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. ALL MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATIONS. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. WE ARE NOT ABLE TO DETERMINE AN EXACT CAUSE FOR THE REPORTED SEPARATION OF THE ZERO-P IMPLANT, WE CAN ONLY ASSUME THAT TOO MUCH FORCE WAS APPLIED DURING BENDING OR TORSION INSERTION CAUSED THE SEPARATION. NOTE THAT INTRAOPERATIVE RE-ASSEMBLY WOULD HAVE BEEN POSSIBLE. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. HOWEVER, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE IS 03/01/2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT CAME APART DURING IMPLANTATION. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274494 ZERO-P LORDOTIC H6 PEEK OVE SYNTHES GMBH 3392360

    Patients

    Seq Age Sex Outcome Treatment
    1