MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHOPAK¿ TRAY; ARTHROSCOPE

Catalog Number KPT1502

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

Patient Problems Death (1802); Shock (2072)

Event Date 03/25/2016

Event Type  Death  

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.Although it is unknown if any medtronic devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on 25-mar-2016 (approximately), the patient underwent balloon kyphoplasty procedure for compression fracture.Post-op, the patient was deceased.It was also reported that death occurred due to hemorrhagic shock due to excessive bleeding.The total amount of intra-op bleeding was reported to be 5600 cc, blood clotting was decreased.Unspecified other implants were also reported to be used in the surgery.The hospital considered the causal relationship between death and balloon kyphoplasty is not related due to massive loss of blood.They determined to perform surgery using instruments together to prevent complications as the patient had two locations of compression fractures, at thoracic and lumbar.No tumor was observed.

• Brand Name: KYPHOPAK¿ TRAY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5684439
• MDR Text Key: 46067023
• Report Number: 2953769-2016-00039
• 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: Physician
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: KPT1502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/27/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death