MAUDE Adverse Event Report: CEMENT DELIVERY INJECTION DEVICE WITH TUBE; DISPENSER, CEMENT

Patient Problems Dysphagia/ Odynophagia (1815); Hair Loss (1877); Pain (1994); Weight Changes (2607); Nervous System Injury (2689); Device Embedded In Tissue or Plaque (3165); Vertebral Fracture (4520)

Event Date 05/11/2021

Event Type  Injury  

Event Description

Patient called to report a product issue and adverse event she experienced during a kyphoplasty procedure she had on (b)(6) 2021.Patient stated after the procedure she felt like a nail was going through her vertebrae, through her spinal column, and pushing through the top of the spine.Patient stated she was referred to a surgeon to assess the bulge on her neck and they ordered an mri which showed pieces of bone cement in her spinal column.Patient learned online of a recall of a bone cement injection device and is concerned that could be what was used during her procedure.She stated she has a large bulge on her neck and had trouble swallowing, weight fluctuation, cervical stress fractures, and hair failing out.Patient stated she can¿t lean against the bulge on her neck and was told by a doctor that it appears to be inoperable.She said she was told she could become paralyzed at any moment.Reference report mw5144910.

• Brand Name: CEMENT DELIVERY INJECTION DEVICE WITH TUBE
• Type of Device: DISPENSER, CEMENT
• MDR Report Key: 17611096
• MDR Text Key: 322184548
• Report Number: MW5144909
• Device Sequence Number: 1
• Product Code: KIH
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 42 KG