MAUDE Adverse Event Report: ALPHATEC SPINE, INC ARCUS GUIDED ACCESS SYSTEM - DIAMOND TIP, STERILE; NEUROSURGICAL NERVE LOCATOR

Model Number 16122-01-S

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not returned.If any additional information is provided, a supplemental report will be submitted.

Event Description

After insertion in the pedicle, the plastic handle became loose on the cannula and could not be used to spin and pull out.This caused a delay in surgery.No patient injury reported.

• Brand Name: ARCUS GUIDED ACCESS SYSTEM - DIAMOND TIP, STERILE
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12304958
• MDR Text Key: 267628785
• Report Number: 2027467-2021-00060
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00190376240268
• UDI-Public: 00190376240268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2021

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
• Device Operator: No Information
• Device Model Number: 16122-01-S
• Device Catalogue Number: 16122-01-S
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR