BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUINTEX DYNAMIC PLATE 3-LEVEL 55MM

    MDR report key: 16486661 · Received March 6, 2023

    Report

    Report Number
    9610612-2023-00045
    Event Type
    Injury
    Date Received
    March 6, 2023
    Report Date
    July 27, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    KWQ
    PMA / PMN Number
    K100243
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: WE RECEIVED ONLY A METAL SHAVING. WE MADE A MICROSCOPICAL INVESTIGATION OF THE RECEIVED METAL- SHAVING. IN TERMS OF SHAPE AND LENGTH, IT COULD BE THE CHIP THAT ARISE WHEN PART OF THE SCREW THREAD IS SHEARED OFF WHEN THE SCREW IS SCREWED IN. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. THE REVIEW OF THE RISK ANALYSIS AFTER INVESTIGATION REVEALED THAT THE APPLICABLE FAILURE MODE IS RATED WITH SEVERITY OF 4(5). ACCEPTABLE PROBABILITY OF OCCURENCE: 5000 PPM. ACTUAL FAILURE OCCURENCE:15 PPM. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY X PROBABILITY OF OCCURANCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: WITHOUT THE SCREW OR THE OTHER COMPONENTS AVAILABLE FOR INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE OCCURRENCE OF THE SHAVING CANNOT BE DETERMINED. THE REASON FOR SHAVINGS LIKE THE PRESENT ONE AND IN THE PAST WAS A NOT CORRECT PLACED SCREW IN THE SCREW SLOT OF THE PLATE. THE THREAD OF THE SCREW WAS SHAVED OFF AT THE EDGE OF THE SCREW SLOT OF THE PLATE. THE EDGE OF THE PLATE SHOWS ESPECIALLY SIGNS OF WEAR TOO IN SUCH CASES. THE SURGICAL TECHNIQUE POINTS OUT, THAT THE QUINTEX SCREW MAY BE DAMAGED OR INSUFFICIENTLY LOCKED IF IT IS NOT CORRECTLY ENGAGED IN THE HOLD OR SLOT OF THE QUINTEX PLATE. CONCLUSION AND PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SC634T - QUINTEX DYNAMIC PLATE 3-LEVEL 55MM. ACCORDING TO THE COMPLAINT DESCRIPTION, A SCREW CHIP CAUSED A POST-OPERATIVE OESOPHAGEAL INJURY. THIS WAS NOT DETECTED DURING INITIAL TREATMENT AND WAS REMOVED DURING REVISION. THE PATIENT IS IN INTENSIVE MEDICAL CARE. THE INITIAL SURGERY WAS TREATMENT FOR A HERNIATED DISC, WITH STENOSIS AND MYELOPATHY HWK 3/4 AND ACDF HWK 4/5 WITH PSEUDOARTHROSIS OF HWK 3-5. A QUINTEX PLATE AND SIX (6) 4.0MM SCREWS HAD BEEN IMPLANTED AT THAT TIME. A REVISION WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4) ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730762 QUINTEX DYNAMIC PLATE 3-LEVEL 55MM IMPLANTS CERVICAL STABILISATION KWQ AESCULAP AG SC634T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention