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

Catalog Number	EI225508
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event description: during implantation, the x-pac llif cage was expanded 2mm as verified by imaging and the surgeon was satisfied with the outcome.The first follow up visit was during (b)(6) 2023 and the patient was doing well and reported no pain.However, during a follow up visit on (b)(6) 2023, the patient reported that pain had developed.The surgeon requested an image and noted that the implanted cage had reduced in height.The surgeon indicated that the cage would need to be replaced and the revision surgery was completed on (b)(6) 2023 manufacturers narrative: the explanted cage was received at ei and a thorough visual inspection of the implant was conducted under 10x magnification.No anomalies were noted on the returned implant.All currently commercialized expanding innovations x-pac cages are designed with the same lifting and locking mechanism with differences limited to size offerings between the cage types.There has been implantation of thousands of x-pac tlif and llif cages since clearance with no reports of confirmed functional anomalies.Review of lot history records show that the subject device met all release criteria with no non-conformances noted for the manufacturing run.Based on the above investigation, the cause of the loss of height for this implant can not be attributed to a malfunction.
Event or Problem Description
A x-pac lateral cage was initially implanted on the patient on (b)(6) , 2023.During implantation, the cage was raised by two clicks as verified by imaging and the doctor was satisfied with the outcome.The first follow up visit was during (b)(6) 2023 and the patient reported no pain.However, during a follow up visit on (b)(6) 2023, the patient reported pain had developed.Due to the reported pain, the doctor requested an image and noted that the implanted cage had reduced height.The doctor indicated that the cage would need to be removed and efforts were underway to schedule the patient for the removal.Ei requested to be present during the removal of the cage and that the explanted cage be made available to ei engineers.Expanding innovations ceo was present for the explantation on (b)(6) 2023 and returned the explanted device to expanding innovations engineers for further evaluation.A cage from a different supplier was used to replace the explanted ei cage.
Additional Manufacturer Narrative
Event description: during implantation, the x-pac llif cage was expanded 2mm as verified by imaging and the surgeon was satisfied with the outcome.The first follow up visit was during (b)(6) 2023 and the patient was doing well and reported no pain.However, during a follow up visit on (b)(6) 2023, the patient reported that pain had developed.The surgeon requested an image and noted that the implanted cage had reduced in height.The surgeon indicated that the cage would need to be replaced and the revision surgery was completed on (b)(6) 2023 manufacturers narrative: the explanted cage was received at ei and a thorough visual inspection of the implant was conducted under 10x magnification.No anomalies were noted on the returned implant.All currently commercialized expanding innovations x-pac cages are designed with the same lifting and locking mechanism with differences limited to size offerings between the cage types.There has been implantation of thousands of x-pac tlif and llif cages since clearance with no reports of confirmed functional anomalies.Review of lot history records show that the subject device met all release criteria with no non-conformances noted for the manufacturing run.Based on the above investigation, the cause of the loss of height for this implant can not be attributed to a malfunction.
Event or Problem Description
During implantation, the x-pac llif cage was expanded 2mm as verified by imaging and the surgeon was satisfied with the outcome.The first follow up visit was during (b)(6) 2023 and the patient was doing well and reported no pain.However, during a follow up visit on (b)(6) 2023, the patient reported that pain had developed.The surgeon requested an image and noted that the implanted cage had reduced in height.The surgeon indicated that the cage would need to be replaced and the revision surgery was completed on (b)(6) 2023.

• Brand Name: X-PAC
• Common Device Name: SPINAL CAGE
• Manufacturer (Section D): EXPANDING INNOVATIONS, INC.; 110 pioneer way, suite i; mountain view CA 94041
• Manufacturer (Section G): EXPANDING INNOVATIONS, INC.; 110 pioneer way, suite i; mountain view CA 94041
• Manufacturer Contact: mbithi muthini ; 110 pioneer way, suite i; mountain view, CA 94041 ; 6508613129
• MDR Report Key: 17670600
• Report Number: 3007289746-2023-00001
• Device Sequence Number: 12529805
• Product Code: MAX
• UDI-Device Identifier: 00850001720991
• UDI-Public: 00850001720991
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K20223174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EI225508
• Device Lot Number: 20221028-06FA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White