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

Catalog Number	K09A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
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.
Event or Problem Description
It was reported that the patient underwent balloon kyphoplasty (bkp) at l1 due to primary osteoporosis, compression fracture.During inflation, onse side of the ibt (inflatable bone tamp) ruptured.The volume at that time was was 4 ml, and contrast media leaked.Right before it ruptured, the inflation pressure was unknown.The patient was not allergic to contrast media.It was washed with saline and confirmed with c-arm.The ibt was not replaced, and the operation was performed continually and completed.When it was found that there was no contrast media , cement was injected.No fragment of the balloon remained in the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: a visual and functional review reveal that the balloon has ruptured.The rupture is a pinhole near the proximal peak.This rupture is consistent with the balloon coming in contact with bone spurs with the balloon is inflated in the vertebral body.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: 7272658
• Report Number: 1030489-2018-00231
• Device Sequence Number: 1028798
• 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,Followup
• Report Date (Section B): 05/22/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1