MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K08A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
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 patient was pre-operatively diagnosed with fracture of the vertebral body and underwent unspecified surgery.During surgery, when the balloon was inflated it burst at 120 psi.The product came in contact with the patient.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
Product analysis: visual and optical examination of the ibt balloon identified a sharp cut at the proximal lobe of the balloon.The morphology, location and timing of the balloon rupture is consistent with in vivo contact with sharp object, such as bone splinters.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• MDR Report Key: 7147177
• Report Number: 2953769-2017-00125
• Device Sequence Number: 1145249
• Product Code: HRX
• UDI-Device Identifier: 00613994704009
• UDI-Public: 00613994704009
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 05/01/2018

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: K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR