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

Catalog Number	K09A
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
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.Image review: submitted images appear to display distal balloon portion of the instrument punctured or ruptured.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis :primary osteoporosis type of fracture : compression fracture level operated: l3 procedure: balloon kyphoplasty; it was reported that during surgery, the bone tamp got ruptured while inserting into the vertebral body.Contrast medium leaked from the balloon.It was removed and cleaned.No patient complications were reported as a result of the event.The procedure was completed with the original product.
Additional Manufacturer Narrative
Product analysis: functional evaluation of the ibt balloon identified a sharp cut at the balloon, disallowing inflation.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 ; CH
• MDR Report Key: 6796583
• Report Number: 2953769-2017-00093
• Device Sequence Number: 855109
• 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,Followup
• Report Date (Section B): 11/10/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1