MAUDE Adverse Event Report: EXPANDING INNOVATIONS, INC X-PAC; CAGE

Catalog Number EI2472LT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Disc Impingement (2655)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

This is the first incident of this nature.This incident was the result of the x-pac tlif cage surgical technique guide not being followed during the procedure.This incidence is the result of specifically, the surgeon attempting ed to reposition the cage, post expansion, by applying excessive cephalad/caudal (sagittal plane) forces to the inserter/cannula/cage.This maneuver created extreme forces on the cannula attachment tabs (on the cage) which resulted in the tabs breaking off in the cannula.A complete inspection and functional evaluation was performed upon return of the surgical set to expanding innovations.There was no visible damage to any of the instrumentation and both cannulas and inserters in the set functioned 100% per ei specifications.In addition, production records confirmed that the cage implanted/explanted met all specifications and release criteria.The explanted x-pac cage was not recovered from the hospital.This was our first emdr and was late due to the emdr enrollment process before submitting the report.

Event Description

On (b)(6) 2021, a lumbar revision surgery was performed on a patient where the surgeon attempted to implant the x-pac tlif expandable cage at the l5-s1 level.The l5-s1 disc space was already occupied by an alif cage implanted during a prior surgery on the patient.From the tlif/posterior approach the surgeon attempted to implant the x-pac cage next to the existing alif cage.Post expansion of the x-pac cage, the surgeon attempted to reposition the x-pac cage applying excessive cephalad/caudal (sagittal plane) forces to the inserter/cannula/cage.This maneuver is explicitly prohibited per the x-pac tlif cage surgical technique guide.Upon attempting this maneuverwhile trying to adjust the location of the loaded implant, the back cannula attachment tabs broke off the cage.Both tabs remained in the cannulaattached to the cannula arms upon removal of the cannula indicating none of the broken pieces were left behind in the patient.Post implantation, flouro imaging showed that the x-pac cage appeared to have advanced anteriorly beyond the disc space.The surgeon proceeded to place a third cage (a static plif cage) into the same l5-s1 disc space.The patient was brought back to surgery on (b)(6) 2021 to remove the x-pac cage that was placed anterior beyond the disc space.The removal was performed by a vascular surgeon.

• Brand Name: X-PAC
• Type of Device: CAGE
• Manufacturer (Section D): EXPANDING INNOVATIONS, INC; 110 pioneer way, suite i; mountain view, ca
• Manufacturer (Section G): EXPANDING INNOVATIONS, INC.; 110 pioneer way, suite i; mountain view, ca
• Manufacturer Contact: mbithi muthini ; 110 pioneer way, suite i; mountain view, ca ; 8613129
• MDR Report Key: 11369542
• MDR Text Key: 233259872
• Report Number: 3007289746-2021-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EI2472LT
• Device Lot Number: 20190711-03FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 136