MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC XPEDE; CEMENT, BONE, VERTEBROPLASTY

Model Number CX01B

Device Problems Improper Chemical Reaction (2952); Mechanics Altered (2984)

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not 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 (hcp) via a manufacturer representative regarding a patient who was implanted with a spinal product type for compression fracture.It was reported that that during intra-op of kyphoplasty procedure the paddle doesn¿t spin properly and the cement doughs up too fast.Cement implanted and remains in service.Levels implanted l-3.Labeling followed throughout the procedure.There was a surgical delay of 7 minute due to reported product malfunction.No patient symptoms or complications as a result of this event.There was delay in overall procedure time.There were no cement extravasations.Cement stored at proper temperature(s) before and during the procedure (below 25°c during storage; 23 +/-1°c for 24 hours prior to use).No malfunction of the cds system during use.The cement mixed for 30 seconds.The cement doughy and homogenous prior to delivery into the patient.No further complications were reported.

• Brand Name: XPEDE
• 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: 11550302
• MDR Text Key: 241697852
• Report Number: 1030489-2021-00388
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00643169097797
• UDI-Public: 00643169097797
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: CX01B
• Device Catalogue Number: CX01B
• Device Lot Number: 0010534973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Date Device Manufactured: 01/22/2021
• 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