BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLYDESDALE PTC SPINAL SYSTEM

    MDR report key: 11191905 · Received January 19, 2021

    Report

    Report Number
    1030489-2021-00083
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    January 6, 2021
    Report Date
    September 22, 2021
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    K133205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART#4922045 ; LOT# 96FH ANALYSIS SUMMARY: A VISUAL REVIEW OF THE RETURNED IMPLANT IDENTIFIED A PORTION HAS BEEN BROKEN. MICROSCOPIC EXAMINATION OF THE INSERTER INTERFACE IDENTIFIED DAMAGE TO THE THREADED HOLE AND DEFORMATION ON THE TOP FACE, AND FRACTURE ON ONE SIDE AROUND THE INSERTER TANG INTERFACE, CONSISTENT WITH SIGNIFICANT IMPACT AND TORSIONAL LOADING. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE OF THE BROKEN PORTION OF THE IMPLANT IDENTIFIED A FRACTURE WITH RAYS EMANATING AWAY FROM THE AREA OF CRACK INITIATION, CONSISTENT WITH BRITTLE OVERLOAD. THE OBSERVATIONS ARE CONSISTENT WITH IMPACTION OVERLOAD. 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.

    Additional Manufacturer Narrative · 1

    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 MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH DEGENERATIVE SCOLIOSIS SUGGESTED FOR SPINAL THERAPY. OLIF WAS PERFORMED FOR DEGENERATIVE SCOLIOSIS AT L2-5 .THE IMPLANT LEVEL OF THE REPORTED BROKEN IMPLANT WAS L2/3. INITIAL IMPLANT WAS NOT MDT. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT THERE WAS DAMAGE TO THE SIDE OF THE CAGE INSERTER GRIP (ONE PLACE BEHIND THE CAGE). AFTER PLACING DD TO L2/3, THE CAGE WAS REMOVED ONCE FOR REINSERTING. WHEN THE REMOVED CAGE WAS TRIED TO BE ATTACHED TO THE INSERTER AGAIN, THE GRIP PART WAS NOTED TO BE BROKEN. IT WAS REPLACED WITH A NEW IMPLANT AND PLACED WITHOUT PROBLEMS. BROKEN PART WAS REMOVED AND CLEANED, BUT THE PART WAS NOT TOO SMALL AND DIRT DID NOT COME OFF. IT WILL BE PACKED SEPARATELY FROM THE IMPLANT PRODUCT AND RETURNED. IT IS SAID THAT THE INTERVERTEBRAL ENTRANCE WAS NARROW AND A HEAVY LOAD WAS REQUIRED FOR INSERTION, BUT THE SALES REP COMMENTED THAT IT ALSO MIGHT HAVE BEEN BROKEN DURING REMOVAL BY THE REMOVER. CLYDESDALE INSERTER WAS USED AS THE INSERTER, AND WHEN THE SALES REP CHECKED IT AFTER THE OPERATION, NO ABNORMALITY WAS FOUND. THE CAGE WILL BE RETURNED INCLUDING THE BROKEN PIECES. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. UPDATE; THERE WAS NO HEALTH DAMAGE TO THE PATIENT. IT WAS A SELECTION MISTAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93829 CLYDESDALE PTC SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG 4922045 96FH

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR