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

Catalog Number	81-1514
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2017
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 was discarded after revision (b)(6) 2017.No screws were replaced at that c7 at the surgeon discretion.Plate remains in the patient.Complaint information has been forwarded to neurostructures inc.The manufacturer, who also submitted medwatch 3500a report number 3008853203-2017-00002.
Event or Problem Description
Surgery was c4-c7 acdf and a partial corpectomy on (b)(6) 2016.Cervical plate migration.Screws backed out of the cervical plate at c7.

• Brand Name: TRANSOM ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NEUROSTRUCTURES. INC; 16 technology drive, suite 165; irvine CA 92618
• MDR Report Key: 6407105
• Report Number: 3012120772-2017-00002
• Device Sequence Number: 30778
• Product Code: KWQ
• UDI-Device Identifier: 00841508101819
• UDI-Public: 00841508101819
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 81-1514
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR