MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 15401-11;15100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/14/2023

Event Type  Injury  

Event Description

A female patient underwent a posterior lumbar interbody fusion (plif) at l3-l4 on an unknown date.On (b)(6) 2021, the patient underwent revision surgery for removal and replacement of initial screws and rods at l3-l4.In addition, the surgeon implanted a spacer at l4-l5.Around 18-months postoperatively, the patient presented with additional degenerative disease requiring surgery.The surgeon performed a plif at l2-l3, and her previously implanted construct was extended to t10.The surgeon placed connectors bi-laterally between the existing l3-l4 screws.The patient was reported to be doing well postoperatively.Three months following surgery, it was determined one of the connectors had disconnected from the construct.On (b)(6) 2023, the patient underwent revision surgery.The surgeon exposed the entire construct and noted the patient was fused, and the left side of the construct was intact requiring no additional attention.On the right side of the construct, it was determined that the connector remained attached to the long rod (which was placed medial to the original l3-l5 rod).The side load feature of the connector had become detached from the right caudal l3-l5 rod of the construct.The cause of the disconnection was unable to be determined.Both right side rods, set screws and connector were removed and replaced with a single rod and 9 new set screws.

Manufacturer Narrative

The implants are currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.

• Brand Name: INVICTUS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 17344691
• MDR Text Key: 319291631
• Report Number: 2027467-2023-00041
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376160979;(01)00190376137902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181677
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15401-11;15100
• Device Catalogue Number: 15401-11;15100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female