MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number CX01A

Device Problems Clumping in Device or Device Ingredient (1095); Coagulation in Device or Device Ingredient (1096)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

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 healthcare provider via a manufacturer representative regarding a patient who was implanted with a spinal product type for unknown indication.It was reported that while performing a kyphoplasty procedure and preparing for cement for injection, it was reported that shortly after pouring in the monomer and trying to mix ,the cement became very "clumpy." staff continued to try to mix the cement but it became increasingly difficult as they cement continued to harden in a very short period of time (less than 30 seconds).As a result cement and mixer was discarded and it was replaced with a different cx01b cement and mixer.The case was then successfully complete without issue.Delay was only a couple of minutes to open and mix replacement cement (less than 5 minutes).

• Brand Name: KYPHX HV-R BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11768509
• MDR Text Key: 249304985
• Report Number: 1030489-2021-00561
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097803
• UDI-Public: 00643169097803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: CX01A
• Device Catalogue Number: CX01A
• Device Lot Number: EL70211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2021
• Date Device Manufactured: 02/16/2021
• 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: 83 YR