MAUDE Adverse Event Report: NEUROSTRUCTURES. INC TRANSOM ANTERIOR CERVICAL PLATE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	81-1218
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirming the event were received.Dhr review and product investigation cannot be completed as the product has not been returned because the device remains implanted.Complaint information has been forwarded to (b)(4) the manufacturer.Remains in patient.
Event or Problem Description
Initial acdf surgery at c4-c6 was performed on (b)(6) 2016.Routine follow up at 2 weeks noted no change to the device.Approximately 6 weeks post operatively it was noted that the 18 mm caudal bone screw had backed out 2-3mm from the anterior cervical plate.Patient is asymptomatic.Surgeon is monitoring the patient, and no revision surgery is currently planned.Patient bone quality is unknown.The patient reportedly did not fall prior to the event.It is unknown if the patient complied w/post-operative care instructions.

• Brand Name: TRANSOM ANTERIOR CERVICAL PLATE
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NEUROSTRUCTURES. INC; 16 technology drive, suite 165; irvine CA 92618
• MDR Report Key: 6062584
• Report Number: 3012120772-2016-00013
• Device Sequence Number: 10852542
• Product Code: KWQ
• UDI-Device Identifier: 00841508101666
• UDI-Public: 00841508101666
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2016

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: 81-1218
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2016
• Initial Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR