MAUDE Adverse Event Report: ALPHATEC SPINE, INC PSX; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	320-08103000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a postoperative visit, a radiograph indicated the cage had migrated posteriorly.The patient reported back pain.A revision surgery was performed on (b)(6) 2022.
Additional Manufacturer Narrative
A radiograph was provided which confirmed the event.Visual inspection of the cage found it is full of bone graft and fully closed indicating the surgeon was able to collapse the cage in-situ during the removal process.After removing some of the bone graft material that was dried within the construct there seemed to be no issues that were present.The cage was able to be expanded and functioned as intended.There was sufficient torsional resistance during the expansion process and all the drive screw anti-collapse tines were in place.The root cause is likely a result of the placement of the interbody into the disc space by the user.Labeling review: "warnings/cautions: potential risks identified with the use of these fusion devices, which may require additional surgery, include device component failure, loss of fixation, pseudarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury; precautions:additional care should be taken to ensure a thorough discectomy is completed in order to correctly size, place, and expand the device.An incomplete discectomy may result in difficulty to fully deploy and place the device in its intended position.;possible adverse effects:possible adverse effects include: 1.Initial or delayed loosening, bending, dislocation, and/or breakage of device components.7.Subsidence of the device into the vertebral body.".

• Brand Name: PSX
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 15591903
• Report Number: 2027467-2022-00069
• Device Sequence Number: 2278228
• Product Code: MAX
• UDI-Device Identifier: 00190376396798
• UDI-Public: 00190376396798
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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
• Device Model Number: 320-08103000
• Device Catalogue Number: 320-08103000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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: 68 YR
• Patient Sex: Male