MAUDE Adverse Event Report: GLOBUS MEDICAL GLOBUS-X PAND CAGE

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

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2010

Event Type  Injury  

Event Description

I had a spinal implant used in my neck that is labeled for the back, yet the device is in a physical size and shape that can't be used for it's labeled purpose and will only fit in it's neck for its unapproved purpose.The device is mislabeled and has seemingly dislocated in my neck, and the mfr globus refuses to provide any information concerning the device, lot number, and serial number, etc.It is a globus x pand cage.Ct stated it was dislocated.

• Brand Name: GLOBUS-X PAND CAGE
• Type of Device: GLOBUS-X PAND CAGE
• Manufacturer (Section D): GLOBUS MEDICAL
• MDR Report Key: 7312992
• MDR Text Key: 101595130
• Report Number: MW5075624
• 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: No Information
• 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): Other; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 91