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

Catalog Number	C01A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Pre-op diagnosis: primary osteoporosis.Type of fracture: compression fracture (intravertebral clefts).It was reported that the patient underwent balloon kyphoplasty.Intra-op, after setting the cement on both sides, and when checking for the solidification of the cement on the left side with bone filler device, the doctor felt strange.When the image was checked, it was found that the cement had dislocated to the front, inside from the initial setting site.There was no deviation from the vertebral body.It was felt that maybe because front wall was damaged, the cement was pushed out.The procedure was continued and finished without additional filling of cement due to concerns about further extrusion.It was unknown whether there were any patient complications or not.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The cement had been mixed properly and had been filled in a uniform softness without any viscosity problems.There had been no migration since the migration that occurred initially.Currently, no complications have occurred.

• 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: 9757576
• Report Number: 1030489-2020-00224
• Device Sequence Number: 19460815
• Product Code: NDN
• UDI-Device Identifier: 00643169097865
• UDI-Public: 00643169097865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C01A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1