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

Model Number MSB_UNK_BKP_CEMENT

Device Problem Improper Chemical Reaction (2952)

Patient Problems Edema (1820); Pain (1994)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

As product id was unknown similar device (cx01b) 510(k) number mentioned.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 a consumer (hcp) via field representative regarding a patient who undergone spinal therapy with an indication of vertebral fracture l3.It was reported that during intra-op, cement set up quickly.Procedure went well until it was time to cement.Consumer could not align mixing paddle and mixer and locked up the gears and was able to get some cement into the patient.However, the cement set up rapidly due to the high temperature in the room.Second cement opened and mixed for 30 seconds, but again, cement set up quickly and consumer was only able to deliver a few cc¿s of cement.Cement stored at 68 degrees temperature.Patient has further collapse in that vertebral body.Physician feels this would not have happened if he was able to cement fully.The patient never received the relief and increased the pain in the patient body.A new mri was done and showed that this patient continues to have edema in l3 with approx 75% collapse on the opposite side.No further complications were reported.

• Brand Name: BKP CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10579042
• MDR Text Key: 208318624
• Report Number: 1030489-2020-01338
• Device Sequence Number: 1
• Product Code: NDN
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BKP_CEMENT
• Device Catalogue Number: MSB_UNK_BKP_CEMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other