MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG; ARTHROSCOPE

Catalog Number K09A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/20/2017

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 with primary osteoporosis and compression fracture underwent balloon kyphoplasty.Intra-op, the metal fragment of inflatable bone tamp remained in the patient's body but cement was injected.Whole balloon parts came off, but cement was inserted to the balloon.Patient complications reported as unknown.

Manufacturer Narrative

Product analysis: on the ibt, there is a tear around the entire circumference of the balloon ~5mm from the tip of the balloon.Given the damage is all the way around the balloon the damage could have happened while being pulled back through the cannula.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product image review: submitted images appear to display ruptured ibt.If information is provided in the future, a supplemental report will be issued.

• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel TN 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel TN 2000 ; CH 2000
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6957277
• MDR Text Key: 89566441
• Report Number: 1030489-2017-02223
• 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,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• 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