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

Model Number C01A-J

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Event Description

Information was received from healthcare professional via field representative regarding patient with symptoms of primary osteoporosis, compression fracture involved in the balloon kyphoplasty procedure.It was reported that post-operatively, cement leakage was confirmed in the spinal canal by postoperative ct.The patient had no symptoms such as paralysis and no additional treatment was performed.There was a piercing of the medial pedicle during the procedure, and it seemed that the cement leaked from there.It was possible that the cavity was not formed properly due to the damage of the balloon during the operation.Cement was mixed for 30 seconds.Cement was doughy and homogenous prior to delivery into the patient.Labeling was followed throughout the procedure.On (b)(6) 2021, no information about balloon breakage and the puncture was obtained.On (b)(6) 2021, received additional information that levels treated/implanted- l1.Cement leaked at implanted level.There is no plan for revision surgery.There is no malfunction with the entire products in the kit.

Manufacturer Narrative

This product is not marketed in us but a similar device with product number c01a with 510(k)# k041584 and (b)(4) is marketed in us.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.

• 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 ; SZ 2000
• MDR Report Key: 12553995
• MDR Text Key: 281608396
• Report Number: 2953769-2021-00031
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: C01A-J
• Device Catalogue Number: C01A-J
• Device Lot Number: EL70188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1