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

Model Number	C01B
Medical Device Problem Codes	Leak/Splash (1354); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
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 professional via field representative regarding patient with unknown indication involved in the reported event.Levels implanted- 2.It was reported that intra-operatively, first curved needle was clogged with xpede cement, remixed, and filled with hvr which was too runny.Mix time was 30 seconds for xpede since room temperature was >72 degrees, hvr was mixed for approximately 1 minute but was not doughy upon injection.Hvr was implanted in t5 was too runny through the curved needle and extravasated what it seemed anterior; patient had no symptoms.T6 physician used the cds gun through a regular bone filler.There was a malfunction of the cds system during use.Hvr was too runny, and it was thought to be responsible for the extravasation.Cement was not doughy and homogenous prior to delivery into the patient.There was no delay in overall procedure time.There were no patient symptoms or complications reported as a result of this event.On 2021-aug-25, received additional information that cement extravasation occurred at t6.No revision surgery planned/scheduled to explant the cement that extravasated.Patient with pre-op diagnosis- vertebral compression fracture involved in the kyphoplasty procedure.

• Brand Name: KYPHON 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: 12415549
• Report Number: 1030489-2021-01112
• Device Sequence Number: 17324463
• Product Code: NDN
• UDI-Device Identifier: 00643169097834
• UDI-Public: 00643169097834
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K041584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/02/2021

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: 02/29/2024
• Device Model Number: C01B
• Device Catalogue Number: C01B
• Device Lot Number: 0010758476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1