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

Model Number	EI2511L
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete investigation was initiated upon receipt of the complaint.The product was not returned for evaluation, so a review of specific lot production records was not possible.However, pictures provided by the user facility showed signs of migration posteriorly.It was noted that the original placement of the cage may have been more posterior than normal and that the patient had poor bone quality.It was confirmed upon removal of the cage that there was no decrease in height.The exact cause of the cage migration cannot be determined.
Event or Problem Description
It was reported by the distributor representative that posterior spinal fusion surgery had been performed on a female patient at l5/s1 on (b)(6) 2021.During patient follow up visit to doctor on (b)(6) 2022, it was observed that migration of the implanted cage had occurred posteriorly and that the cage was impinging on the nerve.Revision surgery was scheduled for (b)(6) 2022.On (b)(6) 2022, it was reported that the revision surgery had taken place on the scheduled date.

• Brand Name: X-PAC
• Common Device Name: SPINAL CAGE
• Manufacturer (Section D): EXPANDING INNOVATIONS, INC.; 110pioneer way, suite i; mountian view CA 94041
• Manufacturer (Section G): EXPANDING INNOVATIONS, INC.; 110pioneer way, suite i; mountian view CA 94041
• Manufacturer Contact: mbithi muthini ; 110 pioneer way, suite i; mountain view, CA 94041 ; 6508613129
• MDR Report Key: 13892291
• Report Number: 3007289746-2022-00001
• Device Sequence Number: 6356835
• Product Code: MAX
• UDI-Device Identifier: 00850001720298
• UDI-Public: 00850001720298
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EI2511L
• Device Catalogue Number: EI2511L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female