MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER INFLATABLE BONE TAMP ARTHROSCOPE

Model Number KPT1002

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

Patient Problem Exsanguination (1841)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during a kyphoplasty procedure in a patient diagnosed with primary osteoporosis, compression fracture and intravertebral cleft. It was reported that there was pulsatile bleeding when the bone access needle was inserted, and the inner cylinder was removed. The physician waited for the bleeding to stop with the inner cylinder inserted for about 5 minutes, but the degree of bleeding did not change. The guide pin and osteo introducer were inserted immediately, and cement was filled with bfd. Balloon was not used with the highest priority being to obtain hemostasis. During cement filling, there was a lot of bleeding and cement leaked into the spinal canal from the damaged posterior wall. In the preoperative evaluation, there was pulsatile bleeding due to the insertion of a bone access needle without noticing that there was an aneurysm in the vertebral body. It was not a product defect. There was a delay of less the 60 mins in the overall procedure. The cement was mixed and stored as per ifu. Patient is in hospital and is making satisfactory progress. No neurological symptoms. No patient injury / complication post-surgery. Bone access needle included in the kit kpt1002. Cement used for the surgery remains in patient. Products will not be returned since they were discarded or remained in patient. There was patient injury /complication.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11573609
• MDR Text Key: 242370636
• Report Number: 9612164-2021-01164
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KPT1002
• Device Catalogue Number: KPT1002
• Device Lot Number: 221527206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/26/2021 Patient Sequence Number: 1