MAUDE Adverse Event Report: SPINAL ELEMENTS VENUS ACP; ANTERIOR CERVICAL PLATE SCREW

Model Number	VSF4012
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were received depicting the event.It is confirmed that the two screws at c7 appear to have partially backed out of the plate.No product was returned, no product information was given, and no further evaluation of the product can be completed at this time.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, patient compliance with post-operative care instructions, or if the patient sustained a fall/impact of any sort.There was a two year duration to failure.Internal fixation appliances are load sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.The root cause in this event cannot be determined.
Event or Problem Description
Reportedly the initial three level acdf surgery (c5-c7) was performed in 2016.On (b)(6) 2018, radiographic imaging depicted two screws at c7 had backed out of the plate.Revision surgery is planned but the plate currently remains in the patient.

• Brand Name: VENUS ACP
• Common Device Name: ANTERIOR CERVICAL PLATE SCREW
• Manufacturer (Section D): SPINAL ELEMENTS; 1755 west oak parkway; marietta GA 30062
• MDR Report Key: 7910563
• Report Number: 1067095-2018-00008
• Device Sequence Number: 1399890
• Product Code: KWQ
• UDI-Device Identifier: 00840916118815
• UDI-Public: 00840916118815
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K103137
• 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): 09/06/2018

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: Health Professional
• Device Model Number: VSF4012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/26/2018
• 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: 39 YR