MAUDE Adverse Event Report: NEUROSTRUCTURES, INC. CABO ACP SYSTEM; 4.0MM VARIABLE SELF TAPPING SCREW 16MM

Catalog Number	81-1216
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided is not sufficient for root cause analysis.No lot numbers available.Parts are not available for review.Trend analysis has been reviewed and indicates no pattern for the p/n.This is the second instance from the same clinician as (b)(4).A review of the associated device history files for 81-1216 has not provided any substantial information contributing to the root cause analysis determination.Finished product met specifications.Raw material met specifications.Failure mode is not related to the mechanical properties of the device.There are multiple techniques for the delivery of an anterior cervical plate as with any surgical procedure.Each surgeon must consider the particular needs of each patient and make the appropriate adjustments when necessary and as required.Surgeon should refer to the surgical technique as needed.
Event or Problem Description
Post-op screw breakage in patient.C4-6 acdf.Surgery (b)(6) 2017.Found on routine follow up by clinician.The same clinician as per (b)(4).Patient asymptomatic, plan will be to monitor patient.

• Brand Name: CABO ACP SYSTEM
• Common Device Name: 4.0MM VARIABLE SELF TAPPING SCREW 16MM
• Manufacturer (Section D): NEUROSTRUCTURES, INC.; 16 technology drive; suite 165; irvine CA 92618
• MDR Report Key: 6973506
• Report Number: 3008853203-2017-00007
• Device Sequence Number: 519042
• Product Code: KWQ
• UDI-Device Identifier: 00841508101673
• UDI-Public: 00841508101673
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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: Physician
• Device Catalogue Number: 81-1216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 77