MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ILLICO POSTERIOR FIXATION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 73600-090

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Weakness (2145); Numbness (2415)

Event Date 07/21/2017

Event Type  malfunction  

Event Description

An elderly male patient underwent a decompression and fusion of l4-l5 and l5-s1 last year, due to intractable and progressive radiculopathy in both legs with neurogenic claudication, progressive weakness and numbness.The illico system from alphatec spine was utilized during this procedure.Subsequent to the surgery, the patient returned to the operating room for a posterior revision of l4-l5 and l5-s1 s/p (status post) for fracturing of a 90mm contoured sine rod, which was implanted during the initial procedure.The operative note further states that there was a fracture in the middle of the rod, and it was completely displaced.Upon an anatomic pathology gross exam, the following model number was found on the fractured rod: 73600-090 [full serial number redacted].

• Brand Name: ILLICO POSTERIOR FIXATION SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6773204
• MDR Text Key: 82029883
• Report Number: 6773204
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2017,08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 73600-090
• Device Catalogue Number: 73600-090
• Device Lot Number: 73600-0906991
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR