BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD 06 SOFT L100 TI

    MDR report key: 2820644 · Received October 31, 2012

    Report

    Report Number
    8030965-2012-01167
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES AT S1 BOTH RODS SLIPPED AND WERE HITTING AGAINST THE LOCKING CAP. IT IS VISIBLE THAT THE RODS HAD TO BE HEAVILY BENT IN THE SAGITTAL PLANE TO FIT THE IMPLANTS (TRACES ON ROD INDICATE BEND). ACCORDING TO THE TRACES ON THE RODS AND IN THE SADDLE, AT LEAST THE IMPLANT WITH THE LOCKING CAP 2 MIGHT HAVE NOT BEEN WELL ALIGNED WITH THE ROD, WHICH MIGHT EXPLAIN THE SLIPPAGE OF THE CORRESPONDING ROD. WHEN ONE ROD SLIPS, THERE IS A RISK FOR THE SECOND ROD TO SLIP FROM OVERLOAD. THE RETURNED DEVICE WAS ANALYZED FOR CONFORMANCE TO SPECIFICATIONS AND A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. THERE WERE NO ABNORMAL FINDINGS. NO PRODUCT FAULT COULD BE DETECTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MFG DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFO FROM A FACILITY IN (B)(4) REGARDING A REVISION PROCEDURE (UNK DATE); ARTHRODESIS, REQUIRED DUE TO LOOSENING OF ROD SCREWS, BILATERALLY AT S1. THE RODS LEFT AND RIGHT DROPPED/SLID OUT OF THE HEAD (LOCKING CAPS WERE STILL ATTACHED). THERE WAS NO BREAKAGE OF THE IMPLANT. METALLOSIS PRESENCE OF BILATERAL REGION AND PSEUDOARTHROSIS WERE NOTED. THIS IS REPORT #3 OF 6 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION ARTHRODESIS, AS THE LOCKING CAP ON SCREWS S1 (BILATERAL) CAME LOOSE. THE RODS LEFT AND RIGHT SLID OUT OF THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD 06 SOFT L100 TI ROD HSB SYNTHES GMBH 3789701

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention