MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS¿ SPINAL FIXATION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	15704-065-040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
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 was no allegation of implant malfunction.Based on the information provided, a root cause could not be determined.If additional information is received, a follow-up report will be submitted.
Event or Problem Description
During an l3-l4 cortical screw case, the surgeon advanced a 6.5mmx40mm screw and saw the lamina fracture cranial and caudal to the shank during insertion.There are no plans for additional surgery.The surgeon will continue to monitor the patient.

• Brand Name: INVICTUS¿ SPINAL FIXATION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 15298866
• Report Number: 2027467-2022-00053
• Device Sequence Number: 7139163
• Product Code: KWP
• UDI-Device Identifier: 00190376225289
• UDI-Public: (01)00190376225289
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192938
• 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): 07/26/2022

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
• Device Model Number: 15704-065-040
• Device Catalogue Number: 15704-065-040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/25/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female