BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 12439896 · Received September 8, 2021

    Report

    Report Number
    1030489-2021-01130
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 14, 2021
    Report Date
    November 9, 2021
    Manufacturer
    CARDIAC SURGERY MFG KERKRADE
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPHIC IMAGE REVIEW RESULT- INTRA-OP IMAGES FOR 3 LEVEL KYPHOPLASTY AP IMAGING ONLY. BY REPORT, CEMENT EXTRAVASATION OCCURRED. IMAGING DOES NOT CORRELATE WITH EVENT DESCRIPTION OF CEMENT TRAVELLING BACK TO SKIN. ADDITIONAL INFORMATION- B5, D3, G3, H6. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- T10, 11 AND L3 VERTEBRAL COMPRESSION FRACTURES INVOLVED IN KYPHOPLASTY PROCEDURE. LEVELS IMPLANTED- T10 AND T11. IT WAS REPORTED THAT INTRA-OPERATIVELY, CEMENT TOOK LONGER TO CURE THAN EXPECTED, STILL SOFT AT 24MINS POST MIX. WHEN THE HCP REMOVED THE OI AFTER THE CEMENT HAD BEEN INSERTED, CEMENT TRACKED BACK ALONG THE PEDICLE TO SKIN LEVEL. SEPARATE MIX FOR T3 WITH NO ISSUES. SOME SWELLING SEEN AROUND T10/11 INCISIONS IMMEDIATELY POST-OP. SURGEON COMMUNICATED TO ANESTHETIST, NO EXTRA PRECAUTIONS NEEDED. CEMENT WAS MIXED FOR 45 SECONDS. CEMENT WAS NOT DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. IT WAS RUNNY. CEMENT EXTRAVASATION OCCURRED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. PATIENT IS ALIVE WITH NO INJURY. ON (B)(6) 2021, RECEIVED INFORMATION THAT CEMENT LEAKED BACK ALONG THE ENTRY TRACT, NOT FROM OUT OF THE VERTEBRAL BODY. CEMENT THAT LEAKED REMAINED AT IMPLANTED LEVEL. SWELLING OCCURRED DUE TO CEMENT LEAK IN THE PATIENT. ON (B)(6) 2021, RECEIVED INFORMATION THAT PART OF THE CEMENT WAS NOT IMPLANTED. CEMENT DID NOT CURE AS EXPECTED, TOOK LONGER. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT NOT ALL THE CEMENT FROM THE MIX WAS USED. NEW PRODUCT WAS OPENED AND USED IN THE SURGERY. ON 2021-OCT-15, RECEIVED ADDITIONAL INFORMATION THAT PRODUCT WAS DESTROYED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # CX01B, 510K # K163032 AND UDI #: (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- T10, 11 AND L3 VERTEBRAL COMPRESSION FRACTURES INVOLVED IN KYPHOPLASTY PROCEDURE. LEVELS IMPLANTED- T10 AND T11. IT WAS REPORTED THAT INTRA-OPERATIVELY, CEMENT TOOK LONGER TO CURE THAN EXPECTED, STILL SOFT AT 24MINS POST MIX. WHEN THE HCP REMOVED THE OI AFTER THE CEMENT HAD BEEN INSERTED, CEMENT TRACKED BACK ALONG THE PEDICLE TO SKIN LEVEL. SEPARATE MIX FOR T3 WITH NO ISSUES. SOME SWELLING SEEN AROUND T10/11 INCISIONS IMMEDIATELY POST-OP. SURGEON COMMUNICATED TO ANESTHETIST, NO EXTRA PRECAUTIONS NEEDED. CEMENT WAS MIXED FOR 45 SECONDS. CEMENT WAS NOT DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. IT WAS RUNNY. CEMENT EXTRAVASATION OCCURRED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT. PATIENT IS ALIVE WITH NO INJURY. ON 2021-AUG-17, RECEIVED INFORMATION THAT CEMENT LEAKED BACK ALONG THE ENTRY TRACT, NOT FROM OUT OF THE VERTEBRAL BODY. CEMENT THAT LEAKED REMAINED AT IMPLANTED LEVEL. SWELLING OCCURRED DUE TO CEMENT LEAK IN THE PATIENT. ON 2021-AUG-19, RECEIVED INFORMATION THAT PART OF THE CEMENT WAS NOT IMPLANTED. CEMENT DID NOT CURE AS EXPECTED, TOOK LONGER. ON 2021-AUG-20, RECEIVED ADDITIONAL INFORMATION THAT NOT ALL THE CEMENT FROM THE MIX WAS USED. NEW PRODUCT WAS OPENED AND USED IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335257 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN CARDIAC SURGERY MFG KERKRADE CX01B-C 221410256

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female