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 or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2017
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
It was reported that the patient underwent balloon kyphoplasty procedure on t12 spine level due to primary osteoporosis and compression fracture.Intra-op, during cement injection, the cement leaked out along the side wall of the vertebral body and leaked from the diseased vertebra (t12) to the side wall of the l1.The surgeon considers that the cement leakage occurred because the widening of the balloon might have been excessive.The surgeon judged that this event has no influence on the patient.The cement was stored at a proper temperature before and during the procedure; and was mixed for less than 9 minutes.The cement was doughy and homogeneous prior to delivery into the patient.No patient complications were reported as a result of this event.

• 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: 6950752
• Report Number: 1030489-2017-02201
• Device Sequence Number: 795632
• Product Code: NDN
• UDI-Device Identifier: 00613994583215
• UDI-Public: 00613994583215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1