MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHOPAK TRAY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number KPT1502

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem Extravasation (1842)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Report source: foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturing representative regarding patient with compression fracture for spinal therapy.It was an intra-op event.It was reported that ibt failed during the first insertion attempt into the vertebral body because there was a hole in the balloon and contrast media leaked into the vertebral body.Rapture occurred during inflation.Pressure was 100.Volume prior to rupture was 2ml.It was confirmed that there was no issue with ibt.There was a delay in overall procedure.Less than 60 mins.No fragments of balloon left in patient.Patient not allergic to contrast media.It was cleaned with saline via osteo introducer no further patient symptoms reported.No further complications reported regarding the event.Update: 2020-jul-21; therapy used was percutaneous vertebroplasty to treat ovf.

• Brand Name: KYPHOPAK TRAY
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10318716
• MDR Text Key: 201734787
• Report Number: 2953769-2020-00016
• Device Sequence Number: 1
• Product Code: LXH
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KPT1502
• Device Catalogue Number: KPT1502
• Device Lot Number: 219947526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 07/24/2020
• 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 Age: 79 YR