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

Catalog Number K13A

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

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.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 Description

It was reported that on (b)(6) 2017, patient presented with pre-op diagnosis as: ankylosing vertebral hyperostosis and intravertebral clefts.For which patient underwent balloon kyphoplasty.Intra-op, after balloon was inserted in the vertebral body, the balloon was able to be inflated without problem.When deflating balloon, the marker (made of platinum iridium alloy) looked somewhat distorted.It was removed and checked visually.Although no breakage was observed, the shaft part was bent a little.Repeated removal and insertion was not conducted.The marker before inflation was normal.Product came in contact with the patient and no patient complications were reported as a result of this event.

• Brand Name: KYPHON XPANDER¿ INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6728002
• MDR Text Key: 80560726
• Report Number: 2953769-2017-00080
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00643169103078
• UDI-Public: 00643169103078
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR