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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Weakness (2145); Tingling (2171)

Event Date 03/23/2019

Event Type  Injury  

Manufacturer Narrative

The following product was also used in the procedure (but was not implanted in the patient): product id: oc01; lot #: rb15k411, 510(k): k152057, fda product code: gei: udi#: asku.Although it is unknown whether these products (cement and the above mentioned product) caused or contributed to the reported event, we are filling this mdr for notification purpose.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

It was reported that on (b)(6) 2019, the patient underwent a surgery due to metastatic bone tumor and compression fracture at t8 and l3 spine.Probes and rf generator were used in this case; and cement was implanted in the patient.The case had gone well and the probes had been placed properly.The cement was doughy and homogeneous prior to delivery to the patient.There were no extravasation.Post-op, approximately on (b)(6) 2019, the patient experienced weakness/tingling in extremities which progressed to paralysis of waist down.According to patient's oncologist, the adverse event was related to surgical procedure, or the implants and instruments used in the surgery.

• Brand Name: KYPHON BONE 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8539171
• MDR Text Key: 142729099
• Report Number: 1030489-2019-00460
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 76 YR