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

Catalog Number C01B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 12/24/2019

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 the patient underwent balloon kyphoplasty surgery due to vertebral compression fracture at l2.Post-op, patient was experiencing an acute inflammatory response and extreme pain at the site of a kyphoplasty surgery.While the doctor is not certain that cement is the cause of this but he was concerned that it might be related.

• Brand Name: KYPHON 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: 9680003
• MDR Text Key: 178137281
• Report Number: 1030489-2020-00151
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097834
• UDI-Public: 00643169097834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180700
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Catalogue Number: C01B
• Device Lot Number: 0010061040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2019
• 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): Other