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

Model Number	19000-35-24
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records revealed no manufacturing or processing related irregularities.The implant was found to be properly manufactured and released in accordance with the device master record.Upon visual inspection, it is noted the screw exhibits failure witness marks seen when there is an added lateral bending movement.The patient's bone density is unknown.The root cause is likely a result of applied lateral force to the screw.Labeling review: 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.
Event or Problem Description
On (b)(6) 2021, a patient underwent a posterior cervical spinal fusion.While attempting to place a 03.5mm x 24 mm polyaxial screw into the c7 vertebral body, it broke mid-shank.The distal portion remains in-situ.The surgeon placed a lateral mass screw next to the broken screw shank.

• Brand Name: INVICTUS OCT SPINAL FIXATION SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12301786
• Report Number: 2027467-2021-00054
• Device Sequence Number: 3671417
• Product Code: NKG
• UDI-Device Identifier: 00190376302676
• UDI-Public: 00190376302676
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/07/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 19000-35-24
• Device Catalogue Number: 19000-35-24
• Device Lot Number: 8733517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other