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

Catalog Number	KE152
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
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 underwent kyphoplasty procedure at l4/l5 due to vertebral compression fractures.Intra-op, a 15mm inflatable bone tamp (ibt) ruptured on the left side of l5.As per the surgeon there must have been a bone shard or something hard within the left side of l5 that ruptured the ibt that was inserted.The procedure was sucessfully completed with the original product.No fragments of the ibt remained iniside the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: the inflatable bone tamp (ibt) had been cut the full circumference of the balloon perpendicular to the shaft of the ibt.This type of damage is consistent with the balloon being cut by bone in the disc space then being damaged while retracted through the tube.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7271051
• Report Number: 1030489-2018-00222
• Device Sequence Number: 2378270
• Product Code: HRX
• UDI-Device Identifier: 00643169143777
• UDI-Public: 00643169143777
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: KE152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1