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

Catalog Number C01B

Device Problem Leak/Splash (1354)

Patient Problem Numbness (2415)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

X-ray image review results: single lateral image of t6 kyphoplasty shows extravasation of cement from the posterior aspect of the vertebral body.By report, it is midline into the spinal canal.There is a substantial height loss of the vertebrae.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent kyphoplasty at t6 due to vertebral compression fracture.Intra-op, during cement injection into the vertebral body, cement was noticed to be leaking from the posterior side into spinal canal.When the issue was noticed, the physician stopped the use of cement immediately.Post-op, the patient experienced numbness in feet as a result of this event.Cement was mixed for about 3 minutes and it was doughy and homogeneous prior to delivery into the patient.

Manufacturer Narrative

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

• 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: 8602220
• MDR Text Key: 144794685
• Report Number: 1030489-2019-00525
• 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,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: C01B
• Device Lot Number: 0009517077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2019
• 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
• Patient Age: 67 YR