MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHX® HV-R¿ BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number C01A-J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).This part is not approved for use in the united states; however, the catalog # c01a and 510k # (b)(4) of 'like devices' was cleared in the united states.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 Description

It was reported that patient underwent balloon kyphoplasty procedure to treat osteoporotic vertebral fracture at th12.During procedure, surgeon injected the cement to the left side, cement leakage into caudal intravertebral disc was observed so he stopped injection.The surgeon commented that the caudal endplate of the treated vertebrae might have a crack although he did not confirm it on the x-ray.No patient complications were reported.

• Brand Name: KYPHX® HV-R¿ BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5170929
• MDR Text Key: 29337292
• Report Number: 2953769-2015-00141
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: C01A-J
• Device Lot Number: EL51214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2015
• 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