MAUDE Adverse Event Report: CAMBER SPINE TECHNOLOGIES SPIRA-A

Model Number	SPA-2632-0815
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient went under a l5/s1 alif surgery on (b)(6) 2023.During this procedure, the patient was implanted with a (b)(6) cage packed with infill cbm into the patient's l5/s1 disc space, post-discectomy.The surgeon utilized orthofix's unity anterior lumbar plating system for supplemental fixation, where he implanted an anterior sacral plate secured with two divergent screws into l5 and two convergent screws into s1.There were no conspicuous intra-operative complications other than a redirection of initial trajectory for one sacral screw.The patient left the facility within 24 hours.Two weeks post-op, the patient began experiencing significant pain.X-ray & ct imaging revealed notable back-out and anterior migration of all hardware (plate/screw construct and cage) as well as bone fractures including an l5 coronal fracture through the body's entirety and a transverse s1 fracture.A revision surgery was performed on (b)(6) 2023.The surgeon removed all the implants (plates, screws and cage).The explanted cage (b)(6) showed no visible signs of damage/defect.The surgeon implanted alphaetec's identi-ti standalone alif cage and secured it using the orthros mis screws at l5 and s1 pedicles to provide additional stabilization.The recovery of the patient was quick with no complications post revision surgery.

• Brand Name: SPIRA-A
• Common Device Name: SPIRA-A
• Manufacturer (Section D): CAMBER SPINE TECHNOLOGIES; 501 allendale rd; suite 101; king of prussia PA 19406
• MDR Report Key: 17316304
• Report Number: 3010197239-2023-00001
• Device Sequence Number: 6226270
• Product Code: MAX
• UDI-Device Identifier: B030SPA263208150
• UDI-Public: B030SPA263208150
• Combination Product (Y/N): N
• PMA/510(K) Number: K162986
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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: SPA-2632-0815
• Device Lot Number: CA98917A2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 89 KG