BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY SET/SMALL- STERILE

    MDR report key: 12692006 · Received October 25, 2021

    Report

    Report Number
    8030965-2021-08949
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 28, 2021
    Report Date
    September 28, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO US CQ FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT VBS W/BALLOON SM THE BALLOON WAS PUNCTURED, AND NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF VBS W/BALLOON SM IN THE DEVICE WAS CONSISTENT WITH THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR VBS W/BALLOON SM. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART # 09.804.600S, SYNTHES LOT # J002434, SUPPLIER LOT # 82213553, RELEASE TO WAREHOUSE DATE: 15FEB2021, EXPIRATION DATE: 01FEB2024, SUPPLIER: (B)(4). NCR 51576 WAS GENERATED DURING DATA PARAMETER NOT RECORDED ¿ DOCUMENTAL ISSUE. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE ADVERSE IMPACT IN THE PRODUCT DUE TO DATA PARAMETER NOT RECORDED, SINCE THE PROCESS HAVE INSPECTION CONTROLS IN PLACE THAT ENSURE THAT THE PRODUCT MET THE SPECIFICATION, ALSO THE LINE CLEARANCE RECORDS AND EQUIPMENT RECORDS SUPPORTS THAT THE OPERATION PARAMETER WAS EXECUTED CORRECTLY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 DURING A PERCUTANEOUS VERTEBROPLASTY (L1) TO TREAT A CENTRUM FRACTURE DUE TO OSTEOPOROSIS, THE TRIAL BALLOON WITH THE HELP OF REINFORCED WIRE WAS DEPLOYED IN THE CENTRUM WITHOUT DIFFICULTY. AFTER A BALLOON ON THE LEFT WAS INFLATED, THE BALLOON ON RIGHT WAS FILLED UP WITH 4CC OF SALINE (8 ATM). HOWEVER, ATM ON THE RIGHT BALLOON DID NOT GO FURTHER. THE BALLOON ON THE RIGHT WAS COLLECTED, AND A TINY HOLE WAS FOUND ON THE TIP OF THE BALLOON. ALSO, THE SALINE HAD LEAKED THROUGH THE HOLE. THE PROCEDURE WAS CONTINUED AND A STENT BALLOON WAS DEPLOYED WITHOUT A FURTHER ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY SET/SMALL- STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590307 VERTEBRAL BODY SET/SMALL- STERILE ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH SYNTHES GMBH J002434

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown