MAUDE Adverse Event Report: GLOBUS XPAND SMALL VBR; INTERVERTEBRAL FUSION DEVICE

Device Problems Device Markings/Labelling Problem (2911); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 09/02/2010

Event Type  Injury  

Event Description

Surgeons at (b)(6) implanted the globus xpand small titanium expandable corpectomy cage into my neck without disclosing its use in the neck is not fda-approved.Though designed to match the anatomy of the cervical spine, the device is labeled as a non-cervical system for use in the back, thereby providing false, misleading and omission of material safety info, including but not limited to the actual device-use risk profile when used in the cervical spine of the neck.Post-op imaging studies indicate the device dislocated, but the implanting surgeon did not disclose this or that the device sponsor globus was paying him consulting fees.The device sponsor refuses to disclose the udi info despite repeated requests.

• Brand Name: XPAND SMALL VBR
• Type of Device: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): GLOBUS
• MDR Report Key: 7313039
• MDR Text Key: 101598524
• Report Number: MW5075633
• Device Sequence Number: 1
• Product Code: MQP
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 51 YR
• Patient Weight: 104