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

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a kyphoplasty procedure at t8."while injecting cement into t7-t8 using eggshell technique with balloon deployed, some cement leaked and was left on the outside of the neural foramen".Reportedly, "the cement extravasation occurred through the superior endplate of t7-8 and there might have possibly been a puncture at this site".No patient symptoms were reported and no further information could be obtained.The type of cement used was not specified.

Manufacturer Narrative

(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.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3755710
• MDR Text Key: 18367719
• Report Number: 1030489-2014-02206
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• 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: 03/18/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BKP, SIZE 10/2 IBT
• Patient Age: 00052 YR
• Patient Weight: 97