MAUDE Adverse Event Report: EXPANDING INNOVATIONS, INC. X-PAC; INTERBODY FUSION DEVICE

Model Number	EI2511L
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: X-PAC
• Common Device Name: INTERBODY FUSION DEVICE
• 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: 13060588
• Report Number: 3007289746-2021-00002
• Device Sequence Number: 11587136
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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
• 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: 11/23/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White