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

Catalog Number KE152

Device Problems Break (1069); Material Rupture (1546)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/21/2016

Event Type  Injury  

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.

Event Description

It was reported that patient underwent balloon kyphoplasty for t9 vertebral body compression fracture.Intra-op, the balloon ruptured at 300psi and when the physician went to remove the balloon from the body, the balloon broke at distal end.Distal tip of inflatable bone tamp marker and a portion of balloon broke while trying to remove balloon from the cannula.As contrast blocked the view, sales rep thinks that the marker band at distal end of balloon was left in body and possibly part of balloon.No patient complications were reported.Patient was not allergic to the contrast media.

Manufacturer Narrative

Product analysis :the reported complaint of a balloon rupture was confirmed during product evaluation.A radial tear was observed near the distal peak of the balloon.This observation is consistent with rupture due to contact with bone splinters during instrument usage.Due to the ¿umbrella¿ effect of the radially cut ibt, the ibt was unable to be collapsed and removed from the stylus.The above observations are consistent with intraoperative instrument damage.

• 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): 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: 6180010
• MDR Text Key: 62523780
• Report Number: 2953769-2016-00088
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00643169143777
• UDI-Public: 00643169143777
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123771
• 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,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KE152
• Device Lot Number: 0008165201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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