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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported 6 months postoperatively following an occipito-cervical spinal procedure, radiograph image revealed two bilaterally broken screws.There is no report of patient symptoms.

Manufacturer Narrative

The implants remain in situ.Neither the part number nor the lot number were provided; therefore, a review of device history records cannot be performed.A radiograph image confirmed the event.There is no report of plans for revision surgery.The root cause is unknown.If additional information and/or the device is provided, a supplemental report will be submitted.Labelling review: warnings/cautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.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.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.Postoperative management: postoperative management by the surgeon, including instruction and warning and compliance by the patient, of the following is essential: 1.Patient should be informed and compliant with the purpose and limitations of the implant devices.2.The surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implant devices, as well as an undesired surgical result are possible consequences of any type of early or excessive weight bearing, vibratory motion, fall, jolts or other movements preventing proper healing and/or fusion development.3.In the case of delayed, mal-, or non-union of bone, the patient must continue to be immobilized in order to prevent bending, dislocation, or breakage of the implant devices.Immobilization should continue until a complete bone fusion mass has developed and been confirmed.

• Brand Name: INVICTUS OCT
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHTAEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18849213
• MDR Text Key: 337033358
• Report Number: 2027467-2024-00014
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Prefer Not To Disclose