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

Model Number C01A-J

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 10/10/2020

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 was received from a healthcare professional via a field contact regarding a patient with pre-operative diagnosis of primary osteoporosis, undergoing a percutaneous kyphoplasty for a compression fracture.It was reported that the cement, which was stored and managed at proper temperature, before, and during the procedure was used.After mixing with an appropriate procedure using a cement mixer, when filling the nozzle, the cement hardened clearly faster than usual, and the 3rd to 5th ones could not be filled if not applied stronger force than usual, the sixth one could not be filled.The viscosity was confirmed using one of the five filled nozzles and a plunger.At the time of filling, 1 out of 5 was hardened and could not be filled.No new cement was used.The cement was mixed for 40 seconds.The reported product was used and the operation was successful.There were no patient symptoms or complications as a result of this event.Levels implanted: first lumbar vertebra device status reason: implanted-remains in service it was reported that there was no malfunction with the mixer.Since it was a case that the cement could not be filled from the mixer to bfd nozzle due to the early hardening of the cement, the report includes the mixer.

• 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: 10761988
• MDR Text Key: 213922907
• Report Number: 2953769-2020-00027
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

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
• 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
• Initial Date Manufacturer Received: 10/10/2020
• Initial Date FDA Received: 10/30/2020
• 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
• Patient Age: 82 YR