BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-PAC

    MDR report key: 13060588 · Received December 22, 2021

    Report

    Report Number
    3007289746-2021-00002
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 23, 2021
    Manufacturer
    EXPANDING INNOVATIONS, INC.
    Product Code
    MAX
    UDI-DI
    00850001720298
    PMA / PMN Number
    K201145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLACEMENT OF THE DEVICE IS DICTATED BY THE SURGEON'S PREFERENCE NOT BY THE DESIGN OF THE IMPLANT. IMAGES PROVIDED BY THE HOSPITAL SHOWED ONE OF THE DEVICES TO HAVE BEEN PLACED OR MIGRATED TOO FAR POSTERIORLY. THIS LED TO THE DECISION BY THE SURGEON TO SURGICALLY INTERVENE IN ORDER TO POSITION THE CAGE OPTIMALLY WITHIN THE DISC. THERE WAS NO INTERVENTION AT THE TIME OF SURGERY UNTIL SEVERAL WEEKS LATER. ON A FOLLOW UP CALL TO THE SALES CONSULTANT ON 11/23/2021, THE SALES CONSULTANT REPORTED THAT THE SURGEON HAD REMOVED THE CAGE AND REPLACED IT WITH ANOTHER ONE ON (B)(6) 2021. SUBSEQUENT TO THE FOLLOW UP CALL, EXPANDING INNOVATIONS INC., RECEIVED CT SCANS BUT COULD NOT CONFIRM WHETHER ANY MIGRATION OF THE CAGE HAD OCCURRED POST-OP. THE CAGE HAS NOT BEEN RETURNED TO EXPANDING INNOVATIONS FOR EVALUATION. HOWEVER, REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE CAGE MET ALL RELEASE CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A SALES CONSULTANT ON 11/3/2021 THAT ON AN UNKNOWN DATE, THE SURGEON REPORTED THAT THE PATIENT HAD RETRO PULSING OF AN EXPANDABLE TLIF CAGE. THE SURGEON ALLUDED TO LOWERING THE CAGE AND IMPACTING IT FURTHER INTO THE DISC SPACE WHICH INITIATED THIS COMPLAINT. IT WAS UNKNOWN AT THAT TIME IF THE SURGERY WOULD BE RESCHEDULED. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVED ONE (1) DEVICE. THIS HAPPENED DURING A PLIF PROCEDURE IN WHICH TWO (2) CAGES ARE IMPLANTED INTO A DISC SPACE. ON A FOLLOW UP CALL TO THE SALES CONSULTANT ON 11/23/2021 HE REPORTED THAT · ON (B)(6) THE SURGEON COMPLETED A REVISION. HE REMOVED THE "LOOSE" X-PAC CAGE AND SUCCESSFULLY REPLACED IT WITH ANOTHER X-PAC CAGE. · THE SURGEON STATED THAT HE THOUGHT HE INITIALLY LEFT THE FIRST CAGE TOO LOOSE AFTER HE PUT IN THE 2ND CAGE CAUSING IT TO MIGRATE POSTERIORLY. · THE SALES REPRESENTATIVE RETAINED THE CAGE AND DID HIS OWN REVIEW AND THOUGHT THE EXPLANTED CAGE WORKED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964541 X-PAC INTERBODY FUSION DEVICE MAX EXPANDING INNOVATIONS, INC. EI2511L 00850001720298

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Prefer Not To Disclose Required Intervention