MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K09A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with pre-op diagnosis, primary osteoporosis and compression fracture.Intra-op, the inflatable bone tamp failed during the first insertion attempt into the vertebral body.When pressure was applied to one place while inflating the balloon, it deformed.The balloon was put out of the body once and inflated, it did not inflate as a whole and one place of the balloon inflated like baking a rice cake.A 1 ml of the contrast medium was added to the balloon but the balloon did not inflate (pressure 300psi).The contrast medium was added more and when 1.5 ml was put into the balloon, the balloon deformed in the vertebral body and only a part of it inflated (pressure 380psi).The device came in contact with the patient.No patient complications were reported as a result of the event.After occurrence of the event, a new kit was opened.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38118
• MDR Report Key: 7517492
• Report Number: 1030489-2018-00688
• Device Sequence Number: 16500257
• Product Code: HRX
• UDI-Device Identifier: 00858196001161
• UDI-Public: 00858196001161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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: K09A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1