BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 10533528 · Received September 15, 2020

    Report

    Report Number
    1030489-2020-01281
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Report Date
    February 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: G9010001606 LOT# 0727937W VISUAL AND OPTICAL EXAMINATION IDENTIFIED THAT THE T-BOLT APPEARS TO BE DAMAGED IN SEVERAL LOCATIONS FROM WHAT APPEARS TO BE 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.

    Description of Event or Problem · 0

    PATIENT DEMOGRAPHICS: GENDER- MALE, AGE- 60 YEARS PRE OP DIAGNOSIS: FALSE JOINT OCCURRED IMPLANT DATE: (B)(6) 2019 EXPLANT DATE: (B)(6) 2020 (PLANNED) INITIAL SURGERY DETAILS: PROCEDURE PERFORMED: POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L5/S IN 2011 AND POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L3/4 IN 2019 AND POSTERIOR LUMBAR FUSION (PLF) WAS PERFORMED AT L4/5 ON (B)(6) 2019 IT WAS REPORTED THAT POST OP, PRODUCTS BACKED OUT AND MALPOSITIONED. THE CONNECTOR BACKED OUT AFTER FINAL TIGHTENING. FINAL TIGHTENING OF THE SET SCREW CAME OFF AND FALSE JOINT OCCURRED. THE PATIENT HAD DIFFICULTY IN BOTH STANDING AND SITTING FOR A LONG TIME. THE CONNECTOR OF TSRH RP2 HAD COME OFF AT MULTIPLE PLACES, BUT THE CAUSE WAS NOT MENTIONED. IN THE REPORT, FOUR CONNECTORS WERE REPORTED, BUT IT WAS UNCLEAR IF THEY ALL HAD COME OFF. A RE-OPERATION WAS PERFORMED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: 8292035, UDI#: (B)(4), 510K #: K031967 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

    POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L5/S IN 2011 AND POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L3/4 IN 2019 AND POSTERIOR LUMBAR FUSION (PLF) WAS PERFORMED AT L4/5 ON (B)(6) 2019. IT WAS REPORTED THAT POST OP, PRODUCTS BACKED OUT. THE CONNECTOR BACKED OUT AFTER FINAL TIGHTENING. THE PATIENT HAD DIFFICULTY IN BOTH STANDING AND SITTING FOR A LONG TIME. IT HAD COME OFF THE ROD AT SEVERAL PLACES. IT WAS DIFFICULT FOR THE PATIENT TO STAND AND SIT FOR A LONG TIME. A RE-OPERATION WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999298 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G9010001606 0727937W

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention