MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS OCT SPINAL FIXATION SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 19003-35-32

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

A female patient underwent a posterior cervical fusion procedure.Around 6 months postoperatively, a radiograph image revealed a broken screw at c1.The patient is asymptomatic.There are no plans for revision surgery.The surgeon will continue to monitor the patient.

Manufacturer Narrative

The implant remains in-situ.No evaluation possible.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, the root cause could not be determined.The implant was used for treatment, not diagnosis.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.

Manufacturer Narrative

Additional information: d6a.05/10/2023.

• Brand Name: INVICTUS OCT SPINAL FIXATION SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• 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: wes channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18373140
• MDR Text Key: 331109692
• Report Number: 2027467-2023-00091
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00190376303871
• UDI-Public: (01)00190376303871
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K203125
• 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,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19003-35-32
• Device Catalogue Number: 19003-35-32
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2023
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female