MAUDE Adverse Event Report: INNOVASIS, INC AXHA PEEK IBF SYSTEM; INTERBODY FUSION DEVICE

Model Number	AX,14X30X14DEG
Health Effect - Clinical Codes	Pain (1994); Abdominal Distention (2601); Vertebral Fracture (4520)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ax143014 is an implanted part of the axha stand alone alif system.The axha standalone alif system is an intervertebral body fusion device for use in patients with degenerative disc disease (ddd) at one or two contiguous levels of the lumbar spine.Surgeons using this system select an appropriate size implant using trials to determine best fit.Once size is selected, the implant is inserted and secured in place using screws.Hyperlordotic implants those with a lordotic angle greater than or equal to 20 are indicated for use with a supplemental spinal fixation system.The surgical technique guide stresses importance of patient selection, implant size selection, and patient compliance with postoperative care instructions in order to increase the likelihood of favorable surgical outcomes.Summary damage to the implant none observed, per surgeon the implant functioned as expected and showed no signs of damage or defect.Patient impact fracture of superior portion of l5, back pain.Revision surgery did not reverse settling, but alleviated back pain and patient is reported as doing well.No difficulties during surgery, very smooth surgery, no issues making a size choice and surgeon was very satisfied with outcome prior to subsequent issues.Patient health/selection female, early 60s, bone density scan showed reasonably good bone, however there was some osteopenia.
Event or Problem Description
On (b)(6), 2021.Innovasis received a phone call from distributor (b)(4).Informing that dr.(b)(6) used an ax cage several weeks ago and the patient has a vertebral body fracture on l5.It was also noted that nothing went wrong with cage or system itself.Timeline (b)(6) 2020 patient surgery for back pain, l4 5-l4 5s1, lack of lordosis.Used 2 cages with high degree of lordosis 14mm 14 cage at l5s1, 16mm 20 at l4-l5.Patient developed ogilvie syndrome bloating gi issues post op ileus, required medical treatment 1 week hospitalization which went well.Ct scan for ileus shows a little settling of the implant.Note ileus not specific to implant device; related to any abdominal procedure.(b)(6) 2020, 2 weeks after surgery severe back pain, ct scan shows a lot more settling subsidence.(b)(6) 2020 revision surgery performed, posterior fixation.Once pedicle screws were implanted the settling stopped.The implant has maxed out on subsidence, cage all the way into the vertebral body.Revision helped patient's back pain and she is now doing very well (b)(6) 2021.

• Brand Name: AXHA PEEK IBF SYSTEM
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): INNOVASIS, INC; 614 e. 3900 south; salt lake city UT 84107
• MDR Report Key: 11436174
• Report Number: 3004719693-2021-00001
• Device Sequence Number: 19777375
• Product Code: MAX
• UDI-Device Identifier: M711AX1430141
• UDI-Public: +M711AX1430141/$$71901/Q1U
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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 Expiration Date: 11/30/2022
• Device Model Number: AX,14X30X14DEG
• Device Catalogue Number: AX143014
• Device Lot Number: 1901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR