BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OIC PEEK SIZE 10 MM - 4DEG

    MDR report key: 3775540 · Received April 28, 2014

    Report

    Report Number
    0009617544-2014-00193
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE REPORTED EVENT OF OIC PEEK SIZE 10 MM - 4DEG CAGE BREAKAGE DURING INSERTION WAS CONFIRMED BY VISUAL INSPECTION OF THE RETURNED PRODUCT. THE MANUFACTURING RECORDS REVIEW DID NOT REVEAL ANY MANUFACTURING ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FURTHER ADVERSE EFFECTS FOR THE PATIENT WERE REPORTED. THE SURGICAL TECHNIQUE STATES THAT THE CAGE MUST BE INSERTED GENTLY AND PROGRESSIVELY INTO THE DISC SPACE. DEFORMATION TO THE CAGE INDICATES THAT THE FRACTURE RESULTED FROM A CANTILEVER LOAD. RESULTS OF A MATERIAL ANALYSIS CONDUCTED PREVIOUSLY, INDICATED THAT THE CAGE FRACTURE WAS DUE TO BRITTLE OVERLOAD AND THAT EXCESSIVE FORCE WAS MOST LIKELY USED DURING INSERTION OF THE CAGE. THEREFORE, AS A RESULT OF THIS INVESTIGATION, THE LIKELY ROOT CAUSE OF THIS EVENT IS DUE TO SURGICAL TECHNIQUE AND/OR PATIENT RELATED FACTORS. CONCLUSION: AS A RESULT OF THIS INVESTIGATION, THE LIKELY ROOT CAUSE OF THIS EVENT IS DUE TO SURGICAL TECHNIQUE AND/OR PATIENT RELATED FACTORS. HOWEVER, THE EXACT CAUSE CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL IN NATURE.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: PER THE CORRESPONDENCE, THE EVENT HAS BEEN FURTHER CONFIRMED. THE OIC PEEK 25X10X4 DEGREE CAGE HAS FRACTURED DURING INSERTION OF THE IMPLANT. THE SURGEON CONSIDERED THE INTERVERTEBRAL SPACE WAS NARROW; THEREFORE, EXCESSIVE FORCE MAY HAVE BEEN USED. THE MANUFACTURING RECORDS REVIEW DID NOT REVEAL ANY RELEVANT MANUFACTURING ISSUES TO THE REPORTED EVENT. THE SURGICAL TECHNIQUE STATES THAT THE CAGE MUST BE INSERTED GENTLY AND PROGRESSIVELY INTO THE DISC SPACE AND TO ENSURE THAT THE INTERVERTEBRAL SPACE IS ACCESSIBLE, THE CONTRALATERAL DISTRACTOR IS LEFT IN PLACE DURING THE CAGE PLACEMENT. CONCLUSION: EXCESSIVE IMPACTION FORCE IS THE LIKELY ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY, WHEN THE SURGEON TRIED TO INSERT OIC PEEK USING INSERTER, OIC PEEK BROKE. THEREFORE, THE SURGEON REMOVED BROKEN OIC PEEK. THE SURGEON CONSIDERED THE INTERVERTEBRAL SPACE WAS NARROW. THE SIZE OF OIC PEEK WAS CHANGED AND THE OPERATION WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY, WHEN THE SURGEON TRIED TO INSERT OIC PEEK USING INSERTER, OIC PEEK BROKE. THEREFORE, THE SURGEON REMOVED BROKEN OIC PEEK. THE SURGEON CONSIDERED THE INTERVERTEBRAL SPACE WAS NARROW. THE SIZE OF OIC PEEK WAS CHANGED AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255111 OIC PEEK SIZE 10 MM - 4DEG IMPLANT-SPACER MAX STRYKER SPINE-FRANCE 64161

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR