MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARCUS; NEUROSURGICAL NERVE LOCATOR

Model Number	16122-01-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device did not return for evaluation.Photographs were not provided; therefore, the complaint cannot be confirmed.A review of device history records showed no manufacturing or processing related irregularities.Based on the information provided, the root cause cannot be determined.If additional information and/or the device are provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that during a procedure the guided access system broke into two pieces.No pieces were left in the patient.

• Brand Name: ARCUS
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• 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: 19817616
• Report Number: 2027467-2024-00084
• Device Sequence Number: 8679259
• Product Code: PDQ
• UDI-Device Identifier: 00190376240268
• UDI-Public: (01)00190376240268(10)9347506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: 16122-01-S
• Device Catalogue Number: 16122-01-S
• Device Lot Number: 9347506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White