BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 5020420 · Received August 21, 2015

    Report

    Report Number
    1030489-2015-02022
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    November 14, 2014
    Report Date
    September 2, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: XRAYS/CT MYELO TAKEN POST-OP.LEVELS IMPLANTED:L5-S1.UNILATERAL SCREW FRACTURE AT S1 HAS OCCURED.X-RAYS/MYELOGRAPHY SHOW A PAUCITY OF BONE IN THE L5-S1 INTERSPACE.UNKNOWN TIME FOR FUSION PROCEDURE THAT THIS OCCURRED.INITIAL PLACEMENT OF HARDWARE AND SCREW SIZE APPEARS APPROPRIATE.FAILUARE OF BONE FUSION IS A RISK FACTOR FOR HARDWARE FAILUARE.ROOT CAUSE: PATIENT RELATED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL REVIEW CONFIRMS SCREW BREAKAGE AT ABOUT APPROX. ~1 THREAD FROM BASE OF THE BONE SCREW NECK. VISUAL AND OPTICAL EXAMINATION OF THE AREA OF FRACTURE INITIATION DID NOT IDENTIFY A PRE-EXISTING SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. SIGNIFICANT FACTURE SURFACE DAMGE/SMEARING IS NOTED. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE WITH PROGRESSIVE STRIATIONS CONSISTENT WITH CYCLIC FATIGUE. DIMENSIONAL EXAMINATION OF THE NECK DIAMETER OF THE BONE SCREW CONFIRMS THE IMPLANT IS WITHIN PRINT SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR DUE TO CYCLIC FATIGUE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE PATIENT UNDERWENT INITIAL PROCEDURE WHICH WAS L5-S1 MIS TRANSFORAMINAL LUMBAR INTERBODY FUSION USING SEXTANT II AND CAPSTONE.POST OP, ON (B)(6) 2014 THE SCREW BROKE AND THE PATIENT HAD A REVISION SURGERY WHICH WAS AN OPEN PROCEDURE WHERE A NEW S1 SCREW WAS PLACED ALONG SIDE THE OLD SCREW, AND A NEW ROD WAS PLACED IN THE L5 SCREW AND IN THE NEW S1 SCREW. THE DISTAL PART OF THE SCREW REMAINED IN S1 OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553720 N/A APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0098068W

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention