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

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
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 (bkp) due to primary osteoporosis, compression fracture.During the surgery, the ibt (inflatable bone tamp) ruptured at high pressure.The patient was not allergic to contrast media.When inserting the balloon, drilling could not be performed perfectly and the balloon on the right side could not enter.The balloon on the left side was set without problems.When drilling was performed on the right side, the balloon on the left side was not removed.And the balloon on the left side was broken due to drilling on the right side.The balloon's marker part remained in the patient¿s body.So it was removed as much as possible with the forceps from the gastric camera through the osteo introducer.Although the possibility that the balloon remained in the patient¿s body could not be denied, according to the judgment that it was removed successfully as much as possible, the cement was indwelt in the patient¿s body.The procedure was successfully completed with the original product.There was a delay of less than 60 minutes as a result of the event.No patient complications were reported as a result of the event.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7365126
• Report Number: 1030489-2018-00446
• Device Sequence Number: 1636505
• Product Code: HRX
• UDI-Device Identifier: 00643169103061
• UDI-Public: 00643169103061
• 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): 03/23/2018

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: 03/01/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1