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

Model Number	15004-095-090
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation and a lot number was not provided.The root cause is unable to be determined at this time.If any relevant, additional information is provided, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2021, a (b)(6) y/o male underwent a spinal fusion at l2-l3 & l4-l5 ltp with t10-p psf.Around 2 months postoperatively, the patient reports to hearing a loud crack while getting up from a chair.The patient reports to having an increase in symptoms.A radiograph reveals screw loosening with broken iliac screw.A revision surgery was performed with l5-s1 tlif, replacement of l4 screws and connecting to superior construct.The broken shank remains in 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: 13481112
• Report Number: 2027467-2022-00001
• Device Sequence Number: 4493171
• Product Code: KWP
• UDI-Device Identifier: 00190376136554
• UDI-Public: 00190376136554
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/10/2022

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?: Yes
• Device Model Number: 15004-095-090
• Device Catalogue Number: 15004-095-090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/08/2022
• 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 Age: 57 YR
• Patient Sex: Male