MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG ARTHROSCOPE

Catalog Number	KE202
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
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 the patient underwent kyphoplasty surgery at l1 due to rheumatoid arthritis, osteoporosis.Intra-op, under fluoroscopic monitoring bilateral kyphoplasty needles were placed through the pedicles of l1 into the anterior aspect of the vertebra.The right balloon was able to be inflated 3.5 cc but the left balloon ruptured at 2 cc.A replacement balloon was placed but during inflation the right balloon also ruptured.The balloons were then removed.Cement was then pulled injected through each cannula with approximately 3 cc of regular cement.There is a good bilateral distribution of cement throughout the vertebral body.The product came in contact with the patient.No patient complications were reported due to this event.

• Brand Name: ARTHROSCOPE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• MDR Report Key: 8924923
• Report Number: 2953769-2019-00013
• Device Sequence Number: 13985322
• Product Code: HRX
• UDI-Device Identifier: 00763000025670
• UDI-Public: 00763000025670
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 08/23/2019

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 Expiration Date: 03/22/2020
• Device Catalogue Number: KE202
• Device Lot Number: 0009067286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR