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

Device Problem Collapse (1099)

Patient Problem Failure of Implant (1924)

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

No device evaluation possible as implant remains in-situ.A radiograph was provided to confirm the event.Neither the part nor lot numbers were provided.Based on the information provided, a root cause cannot be determined.If additional information is received, a supplemental report will be submitted.

Event Description

It was reported a psx cage collapsed postoperatively at l5-s1.The patient is asymptomatic.The surgeon will continue to monitor the patient.There no plans for additional surgery.

• Brand Name: PSX INTERBODY SYSTEM
• Type of Device: 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: 15591081
• MDR Text Key: 306599843
• Report Number: 2027467-2022-00070
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1