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

Model Number C01B

Device Problems Leak/Splash (1354); Improper Chemical Reaction (2952)

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

Event Date 08/09/2021

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 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
• 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: david gustafson ; 1800 pyramid place; memphis, TN 38132 ; 7635149628
• MDR Report Key: 12415549
• MDR Text Key: 270341684
• Report Number: 1030489-2021-01112
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097834
• UDI-Public: 00643169097834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041584
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2021
• Date Device Manufactured: 07/12/2021
• 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