MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPEDE BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number CX01B

Device Problem Chemical Problem (2893)

Patient Problem Death (1802)

Event Date 10/25/2019

Event Type  Death  

Manufacturer Narrative

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 t12-l5 fenestrated screw surgery due to t12-l4 burst fracture.The plan was to cement 4 levels with 8 screws.Intra-op, the patient died.One bone filler was being used per screw.Cement was mixed and 6 bone filler were filled.2 bone fillers could be filled before the cement became too hard to fill anymore.So, another kit was opened to the field.Even after the cement was mixed, it could not be filled in the bone filler.Another bone filler was grabbed for use.As the additional bone filler was being tried to be filled, the doctor wanted another one.The anesthesiologist commented that it was the cement that was causing the issues.The fluid was being squeezed and a call for another anesthesia was taken.A few seconds later, there was no pulse.The doctors were trying to pack the opening and put an ioban on so they could flip the patient to perform cpr.The efforts failed and the patient passed away.Cement was stored at proper temperature (below 25°c during storage; 23 +/- 1°c for 24 hours prior to use).The cement was mixed for 30 seconds.According to the surgeon, cement was not responsible for patient's death.The exact reason for patient's death could not be determined.

• Brand Name: KYPHON XPEDE BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9367281
• MDR Text Key: 167754963
• Report Number: 1030489-2019-01333
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097797
• UDI-Public: 00643169097797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163032
• 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: 11/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: CX01B
• Device Lot Number: 0009888417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR