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

Model Number	CX01A
Medical Device Problem Codes	Clumping in Device or Device Ingredient (1095); Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11768509
• Report Number: 1030489-2021-00561
• Device Sequence Number: 3104654
• Product Code: NDN
• UDI-Device Identifier: 00643169097803
• UDI-Public: 00643169097803
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR