BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 10389373 · Received August 11, 2020

    Report

    Report Number
    1030489-2020-01057
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 15, 2020
    Report Date
    March 12, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: #703854646: G811H403, LOT# 0238256W. VISUAL AND OPTICAL EXAMINATION IDENTIFIED THAT THE TIPS OF THE LOCKING SCREWS HAVE DEFORMATION AT THE TIPS AND THE CONNECTOR BAR HAS BEEN HEAVILY DAMAGED. MICROSCOPIC REVIEW OF THE DEFORMATION OF THE SURFACES INDICATES A TORSIONAL OVERLOAD. THIS IS CONSISTENT WITH EXCESSIVE FORCE. 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

    SIMILAR DEVICE WITH PRODUCT NUMBER (B)(4) AND 510(K)# K121680 IS MARKETED IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR ANCHOR BREAKAGE AFTER IDIOPATHIC SCOLIOSIS FIXATION. IT WAS REPORTED THAT AFTER SCREW WAS REPLACED, CROSS LINK WAS PLACED. MULTI-SPAN WAS MANAGED TO BE PLACED, BUT FX WAS PLACED ON TH7/8. SET SCREW WAS TIGHTENED, BUT IT BECAME UNSTABLE DUE TO WHICH THE SURROUNDING BONE TISSUE WAS SCRAPPED AND CROSS-LINK DID NOT FIT. REVISION SURGERY WAS DONE AS THE CROSS-LINK DID NOT FIT AND EXCESSIVE RESECTION OF SURROUNDING BONE TISSUE WAS PERFORMED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854267 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G811H403 0238256W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention