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

Model Number	55005-105-080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implants remain in-situ.A radiograph image was provided which confirmed the event.The original surgery date is unknown.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.A root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
During a postoperative visit, radiograph image of the patient revealed a right-side iliac screw fracture.The patient is asymptomatic.There are no plans for revision 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 (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: 16452652
• Report Number: 2027467-2023-00012
• Device Sequence Number: 5531000
• Product Code: KWP
• UDI-Device Identifier: 00190376404738
• UDI-Public: (01)00190376404738
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K214006
• 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): 02/28/2023

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: 55005-105-080
• Device Catalogue Number: 55005-105-080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/28/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Unknown