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

Model Number C01A-J

Device Problem Improper Chemical Reaction (2952)

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

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states, however, a like device catalog #c01a, 510k # k180700, and 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

Information received from initial reporter via medtronic field representative regarding an event happened during intra-op for a pre-op diagnosis of primary osteoporosis, and compression fracture.It was reported that the cement was hardened quickly.It was mentioned as after filling the cement into bone filler device, and confirming that it had a good viscosity, cement filling was started.But, the cement hardening progressed suddenly, and was unable to fill the third bone filler device (bfd).It was mentioned as another kit was opened for dealing with it, and operation was completed without any problems.It was mentioned as the cement was stored at temperature of below 25 degrees, and it was in between 22 and 24 degrees prior to use i.E before 24 hours.There was a delay of less than 60 minutes was reported as a result of this event, and no health damage in patient was reported.There were no symptoms reported to patient as a result of this event.There were no complications to patient/physician were reported/anticipated.

• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10633914
• MDR Text Key: 209964505
• Report Number: 2953769-2020-00024
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C01A-J
• Device Catalogue Number: C01A-J
• Device Lot Number: EL70177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• 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