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

Catalog Number	C01B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON HV-R BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8602220
• Report Number: 1030489-2019-00525
• Device Sequence Number: 13998414
• Product Code: NDN
• UDI-Device Identifier: 00643169097834
• UDI-Public: 00643169097834
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: C01B
• Device Lot Number: 0009517077
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/11/2019
• Supplement Report FDA Received Date: 05/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR