MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	15004-055-035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant remains in situ.The identifying lot number was not provided; therefore, a review of the device history records could not be conducted.Radiographs were not provided.There are no plans for revision surgery.The root cause cannot be determined at this time.If additional information is received, a follow-up report will be submitted.
Event or Problem Description
During a postoperative visit, the surgeon noted that the most caudal screw had fractured.

• Brand Name: INVICTUS
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): 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: 15443223
• Report Number: 2027467-2022-00057
• Device Sequence Number: 17541767
• Product Code: NKB
• UDI-Device Identifier: 00190376134949
• UDI-Public: 00190376134949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/18/2022

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
• Device Model Number: 15004-055-035
• Device Catalogue Number: 15004-055-035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/17/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male