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

Model Number CC02A AND CDS2A

Device Problems Burst Container or Vessel (1074); Extrusion (2934)

Patient Problem No Information (3190)

Event Date 04/21/2017

Event Type  malfunction  

Event Description

The balloon was increased sequentially up to about 600 mm of pressure with partial fill.On the right just at the very beginning of inflation of the balloon, the balloon broke with minimal pressure.There was leakage of dye in the vertebral body and then exiting posteriorly.The cement was then inserted, first on the right and this was for a total of 6 ml.The cement was seen to be starting to creep posteriorly.The needle biopsy core was placed into the needle biopsy sheath.The cement was then introduced on the left side.On the left side, cement was sequentially filled into the vertebral body.During the process of filling, the cement was seen to extrude out into the canal.Cement fill was stopped.It was difficult to determine if the cement extrusion was either on the right or the left side due to the dense anterior fill and therefore, the o-arm was brought into the room.This verified placement of the cement on the right side.Procedure became bilateral t12-l1 laminotomy with partial facetectomy without discectomy and without foraminotomy- durotomy repair on the right at l1.

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 6680499
• MDR Text Key: 78814471
• Report Number: 6680499
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/29/2017
• Device Model Number: CC02A AND CDS2A
• Device Catalogue Number: CC02A AND CDS2A
• Device Lot Number: W1476475 AND W1476389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Weight: 83