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

Model Number VSF4012

Device Problems Mechanical Problem (1384); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/29/2018

Event Type  malfunction  

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 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
• Type of Device: ANTERIOR CERVICAL PLATE SCREW
• Manufacturer (Section D): SPINAL ELEMENTS; 1755 west oak parkway; marietta GA 30062
• Manufacturer Contact: peter perhach ; 1755 west oak parkway; marietta, GA 30062 ; 7606071830
• MDR Report Key: 7910563
• MDR Text Key: 121870758
• Report Number: 1067095-2018-00008
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00840916118815
• UDI-Public: 00840916118815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VSF4012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 39 YR