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

Catalog Number C01A-J

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this part is not approved for use in the united states; however a like device catalog # c01a, 510k # k041584, udi# (b)(4) 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent bkp( balloon kyphoplasty) at th8 and th11 and pps (percutaneous pedicle screw) placement and fixation at th10 and th12 due to multiple myeloma.Intra-op, when the cement was filled 3cc on the left side of th8 and 4cc on the right side of th8, the cement leaked into the spinal canal from the vicinity of the pedicle on the right side.The cement spread to the vicinity of th9 along the boundary between the medial side of the pedicle and the posterior wall of the vertebral body.Cement was stored at proper temperature(s) before and during the procedure.The procedure was successfully completed with the alleged product without any delay.There were no patient symptoms or complications reported as a result of this event.

• 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 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9518185
• MDR Text Key: 181736960
• Report Number: 2953769-2019-00022
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C01A-J
• Device Lot Number: EL70118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• 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: 71 YR