MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SPINAL FIXATION SYSTEM; NKB

Model Number	15620
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been removed from the patient nor has the identifying lot number been provided.
Event or Problem Description
Follow up x-ray revealed the tulip of the mod screw had separated from the shank.The tulip remains attached to the rod implanted within the patient.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: NKB
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 10785649
• Report Number: 2027467-2020-00046
• Device Sequence Number: 16870993
• Product Code: NKB
• UDI-Device Identifier: 00190376236124
• UDI-Public: (01)00190376236124
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15620
• Device Catalogue Number: 15620
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/04/2020
• 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
• Patient Age: 59 YR