BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK

    MDR report key: 2921768 · Received January 18, 2013

    Report

    Report Number
    8030965-2013-00168
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NORMAL AND MINOR DEFORMATION TO THREE LOCKING TEETH AND DEFORMATION IN AND AROUND THE LOCKING HEAD WERE FOUND. THIS IS TYPICAL FOR POST TENSIONING WITH THE APPLICATION INSTRUMENT. THE ABSENCE OF THESE DEFORMATIONS IS NOT IN AND OF ITSELF A PROBLEM. IMPLANTS WHICH ARE TENSIONED BY HAND OR ONLY LIGHTLY WITH THE APPLICATION INSTRUMENT MAX NOT EXHIBIT THESE DEFORMATIONS BUT SHOULD NOT IMPEDE IMPLANT PERFORMANCE. BASED ON THESE FINDINGS WE CAN NOT IDENTIFY ANY ROOT CAUSE REGARDING THE FAILURE OF THE RETURNED DEVICES. THE ROOT CAUSE IS THEREFORE INCONCLUSIVE.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(4) REGARDING ZIPFIX IMPLANTS. IT WAS REPORTED THAT A PATIENT HAD PAIN POST OPERATIVELY AND SUBSEQUENTLY HEARD A POP SOUND. IT WAS FOUND THAT 3 ZIPFIX IMPLANTS PULLED OUT OF THE LOCKING HEAD. NO OBVIOUS INITIAL DEFORMITIES OR DAMAGE TO THE IMPLANTS AND NO BONE CUT-THROUGH WHEN THE IMPLANTS PULLED OUT WAS NOTED. THE LOCKING HEAD WAS STILL ENGAGED WITH THE IMPLANT AND RE-LOCKED AFTER REMOVAL. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED AN AGGRESSIVE PRODUCTIVE COUGH POST OPERATIVELY AND REPORTEDLY THERE WERE NO RESPIRATORY ISSUES PRE-OPERATIVELY. THIS IS REPORT #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27447 STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK STERNAL ZIPFIX JDQ SYNTHES GMBH 7795437

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention