MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. KYPHOPAK¿ EXPRESS¿ TRAY; ARTHROSCOPE

Model Number KPE1003-CDS

Device Problem Break (1069)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 03/07/2018

Event Type  Injury  

Event Description

While performing kyphoplasty, the physician described the patient's bone as extremely hard.While putting pressure on the trocar, the device broke and a portion of the needle was retained in the patient's spine.

• Brand Name: KYPHOPAK¿ EXPRESS¿ TRAY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7365186
• MDR Text Key: 103291874
• Report Number: 7365186
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/21/2018

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: Physician
• Device Model Number: KPE1003-CDS
• Device Catalogue Number: KPE1003-CDS
• Device Lot Number: WI520295
• Other Device ID Number: WI518751
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR