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

Model Number	16122-01-S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
During surgery, the needle broke upon impaction into the vertebral body and became lodged in the patient.This caused surgery to be delayed 45 minutes.All pieces were removed from the patient.

• Brand Name: ARCUS
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): ALPHATEC SPINE INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12301837
• Report Number: 2027467-2021-00055
• Device Sequence Number: 17238582
• Product Code: PDQ
• UDI-Device Identifier: 00190376240268
• UDI-Public: 00190376240268
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: No Information
• Device Model Number: 16122-01-S
• Device Catalogue Number: 16122-01-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1