MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number C01A

Device Problem Leak/Splash (1354)

Patient Problem Paralysis (1997)

Event Date 09/08/2018

Event Type  Injury  

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 intra-op, extravasation of cement occurred in the spinal canal due to which the patient got paraplegic post surgery.No other info was available.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Patient underwent a revision surgery around 4 or 5 hours after the first procedure.

• Brand Name: KYPHX HV-R 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: 8018201
• MDR Text Key: 125428705
• Report Number: 1030489-2018-01426
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097865
• UDI-Public: 00643169097865
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K041584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: C01A
• Device Lot Number: EL70014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2017
• 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): Other; Required Intervention