BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR EXTRACTION SCREWDRIVER

    MDR report key: 7739980 · Received August 1, 2018

    Report

    Report Number
    2939274-2018-53161
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    July 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10705034714578
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S HEIGHT REPORTED AS 175 CMS. THIS PATIENT INFORMATION IS UNKNOWN. LOT NUMBER REPORTED AS H170953; HOWEVER, THIS LOT NUMBER COULD NOT BE VALIDATED AS BELONGING TO THE REPORTED PART NUMBER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A C4-C7 ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, THE ZERO-P VARIABLE ANGLE (VA) IMPLANT 8MM HEIGHT CONVEX-STERILE WAS INSERTED AT THE C4-C5 LEVEL. UPON INSERTION WITH THE INSERTION DEVICE, THE PLATE DISENGAGED FROM THE PEEK SPACER. THE SURGEON WAS UNABLE TO COMPLETELY RE-ENGAGE THE PLATE TO THE IMPLANT AFTER NUMEROUS ATTEMPTS. A NEW ZERO-P VA IMPLANT WAS REQUESTED AS THE SURGEON WAS UNCOMFORTABLE WITH TRYING TO FORCE THE IMPLANT ON. UPON REMOVING THE ZERO-P VA IMPLANT FROM THE STERILE FIELD, THE SALES CONSULTANT WAS ABLE TO DISENGAGE THE IMPLANT COMPLETELY WITH CONSIDERABLE FORCE. THE PLATE SEEMED TO BE STUCK HALFWAY DOWN THE TRACK ON THE PEEK SPACER. A NEW ZERO-P VA OF THE SAME SIZE WAS IMPLANTED WITH NO ISSUES. THE INNER SHAFT FOR EXTRACTION SCREWDRIVER WAS REPORTEDLY BROKEN, AND THE FRAGMENT IS STILL LOCATED INSIDE OF A TITANIUM CERVICAL SELF RETAINING SCREW THAT WAS NOT IMPLANTED INTO THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE/S REPORTED: INSERTION DEVICE (PART# 03.647.963, LOT# UNKNOWN, QUANTITY# 1), PEEK SPACER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), SCREWS: ZERO-P VA (PART# 04.613.518, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) INNER SHAFT FOR EXTRACTION SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582845 INNER SHAFT FOR EXTRACTION SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10705034714578

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR