MAUDE Adverse Event Report: MEDTRONIC VERTE-STACK ANATOMIC; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 6240841

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2011

Event Type  Injury  

Event Description

I was implanted with two peek corpectomy cages into the cervical spine (procode mqp).Post-op imaging studies show that one of the two cages dislocated and migrated into the spinal canal.Device-labeling states that use in the cervical spine is an absolute contraindication, yet the review of the device construct shows that the device is designed to fit into the cervical spine.The two part numbers involved are 6240841 and 6240861.Also part number 6240841 expired in 2010, but was implanted in 2011.I will require revision surgery.The implanting surgeon did not disclose the contraindicated use and device-related risk associated with device use in the cervical spine, nor did he disclose he is being paid by the device sponsor.

• Brand Name: VERTE-STACK ANATOMIC
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6910896
• MDR Text Key: 88143522
• Report Number: MW5072570
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994305091
• UDI-Public: 00613994305091
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2010
• Device Model Number: 6240841
• Device Lot Number: TZ3Z
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Weight: 75