MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CEMENT, BONE, VERTEBROPLASTY

Device Problem Leak/Splash (1354)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Neurological Deficit/Dysfunction (1982); Spinal Cord Injury (2432)

Event Type  Injury  

Manufacturer Narrative

Hcp reviews: from the provided description extravasation of cement was noted at the time of kyphoplasty.No imaging is provided.A note is made of cement in canal on the fluoroscopy but the surgical description suggests epidural hematoma as the cause of patient's paraplegia.Epidural hematoma and cement extravasation are known complications of kyphoplasty.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent kyphoplasty surgery from t6-t8 due to fractures in the spine.Post-op, the patient died due to post-op complications.Intra-op, cement was injected 0.5 ml in either side with good containment.Following the injection of the second 0.5 ml of cement, it was noted that there was some extravasation of the cement on the left.There was some cement noted to be extraverted on the left side posteriorly.The remaining injection was ceased, and the bone fillers were removed.The skin wounds were approximated by means of steri-strips and sterile dressings applied.Following the procedure, the patient was having difficulty with sensation from the waist down and difficulty moving her legs bilaterally.This was monitored very closely over the next several hours.The patient was returned to the recovery room in unchanged condition.Due to acute neurological deficit she was transferred to another hospital to the neurosurgeon.She was having a previous history of 3 vessel coronary artery bypass grafting (cabg) who presents to the emergency department after she had a t7 kyphoplasty done at previous hospital in the afternoon.After the procedure, she complained of a burning sensation in both her legs with weakens where she could not move them.Examination was concerning for spinal cord injury.This most likely is from the cement extending into the back.Doctor did look at the fluoroscopy x-ray from previous hospital which did show cement in the spinal cord.And then performed a total t6, total t7 and total t8 laminectomies to repair durotomy and csf leak.There was epidural hematoma found deep to each of these levels.However, there was highly thick compressive clot at t6-t7 causing that several spinal cord compression.This was evacuated.Also, multiple punctures site of dura was seen.After the surgery she completely paralyzed in the lower extremities.After that patient was transferred to another hospital.After that patient has shortened life expectancy.

• Brand Name: CEMENT, BONE, VERTEBROPLASTY
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8765776
• MDR Text Key: 150251029
• Report Number: 1030489-2019-00729
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Weight: 70