MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON® EXPRESS¿ INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number K15B

Device Problem Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).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.

Event Description

Medical history: renal cell carcinoma preoperative diagnosis: vertebral compression fracture it was reported that on (b)(6) 2016, intra-op, ibt ruptured, ibt was inflated to 350 +- psi inflated contra lateral ibt.Then ibt was adjusted again and pressure was decreased to 0 psi.Physician pulled back on inflation syringe.Excessive amount of blood was observed coming out of the cannula.Surgeon did a cut down to see if bleeding was outside of vertebral body and then applied flo seal.Patient was taken to ct scan and was confirmed no bleeding outside of vertebral body.Patient was not allergic to contrast media.Product came in contact with the patient.Patient complications were reported unknown.No patient complications were reported.

• Brand Name: KYPHON® EXPRESS¿ INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5478958
• MDR Text Key: 39631531
• Report Number: 2953769-2016-00017
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041454
• 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: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2016
• Device Catalogue Number: K15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2015
• 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): Other