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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Post Operative Wound Infection (2446); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/05/2023

Event Type  Injury  

Event Description

Information was received via literature review of a retrospective medical record review involving 365 patients who underwent a llif spinal procedure through the ptp approach between january 1, 2021, and december 31, 2021.Data collected included intraoperative characteristics, intraoperative complications, postoperative complications, and hospital stay.Intraoperative complications reported: all rupture, cage subsidence, a vascular injury, and a ureteric injury.Postoperative complications reported: new sensory symptoms, new lower extremity weakness, wound infection, cage subsidence, psoas hematoma, small bowel obstruction and ischemia.Additional information was not available.

Manufacturer Narrative

There was no product return.Radiograph images were not provided.Neither the identifying part nor lot numbers were available.The date provided in b3 is the publication date of the article as the event date was not provided.The root cause could not be determined.

• Brand Name: UNKNOWN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): 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: 18360484
• MDR Text Key: 330932313
• Report Number: 2027467-2023-00087
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other