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

Model Number	15005-075-050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant was used for treatment, not diagnosis.Both implants remain in situ radiograph images were not provided.The identifying lot number was not provided; there, a review of the device history record could not performed.No additional information has been received regarding this event.Based on the information provided, a root cause cannot be determined.If additional information is provided, a supplemental report will be submitted.
Event or Problem Description
A 51 y/o male underwent a posterior lumbar interbody fusion procedure at l4-5 on (b)(6) 2022.Around 4 months postoperatively, a radiograph revealed two broken screws.A revision surgery has not been scheduled.

• Brand Name: INVICTUS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vide roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16595426
• Report Number: 2027467-2023-00023
• Device Sequence Number: 4474628
• Product Code: KWP
• UDI-Device Identifier: 00190376186412
• UDI-Public: (01)00190376186412
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: 15005-075-050
• Device Catalogue Number: 15005-075-050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/22/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male