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

Model Number	19500-56
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a patient underwent revision surgery to have an occipital plate that loosened from the construct removed.Spinal fusion had been achieved; therefore, replacement hardware was not needed.
Additional Manufacturer Narrative
The implant did not return for evaluation.The original surgery date is unknown.Radiograph images were not provided.The report could not be confirmed.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.The root cause could not be determined.Labeling review: "postoperative management: postoperative management by the surgeon, including instruction and warning and compliance by the patient, of the following is essential: patient should be informed and compliant with the purpose and limitations of the implant devices.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.".

• Brand Name: INVICTUS OCT
• Common Device Name: 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18114682
• Report Number: 2027467-2023-00077
• Device Sequence Number: 7609525
• Product Code: NKG
• UDI-Device Identifier: 00190376350042
• UDI-Public: (01)00190376350042
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 19500-56
• Device Catalogue Number: 19500-56
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male