MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; CEMENT, BONE, VERTEBROPLASTY

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Paralysis (1997)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).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.

Event Description

It was reported that patient underwent bkp surgery at l3 for lumbar compression fracture on unknown date.On an unknown date post-op, lump of cement was breaking through the front wall of the vertebral body and stopped in front of anterior longitudinal ligament.The patient complained of numbness in the lower extremity.The surgeon commented he considered it was happened due to vulnerability of bone.Patient complications were reported.Concurrent diseases:osteoporosis it was reported that the initial surgery was performed half a year prior to this event.On unknown date post-op, it was confirmed that the lump of cement had been moved when medical examination.Around the same term, the patient developed leg paralysis.Follow-up observation is required.Dr's comment: it is unknown that the leg paralysis was caused by moved cement.Revision will not be scheduled because the patient is too old.

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5349939
• MDR Text Key: 35684170
• Report Number: 1030489-2016-00081
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• 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): Other
• Patient Age: 00086 YR