MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VBT1315-AVAMAX BALLOON¿13G 15MM; VERTEBROPLASTY BONE CEMENT

Catalog Number	1021315000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Discarded.
Event or Problem Description
It was reported by the sales rep that the kyphoplasty procedure was completed successfully but that two days later, the patient passed away.

• Brand Name: VBT1315-AVAMAX BALLOON¿13G 15MM
• Common Device Name: VERTEBROPLASTY BONE CEMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7951484
• Report Number: 0001811755-2018-01733
• Device Sequence Number: 1499277
• Product Code: NDN
• UDI-Device Identifier: 07613327374469
• UDI-Public: 07613327374469
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1021315000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)
• Outcome Attributed to Adverse Event: Death