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

Catalog Number K15B

Device Problem Inflation Problem (1310)

Patient Problem No Code Available (3191)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Patient codes : (b)(4) (no code available for "change in surgical procedure"), 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 on (b)(6) 2016, patient with vertebral compression fracture, underwent balloon kyphoplasty.Intra-op, upon placement of the osteo-introducer and biopsy, a balloon was placed into broken vertebral body.Upon attempting to inflate the balloon it had not inflated.Another balloon had not inflated under fluoroscopy so the surgeon had taken the balloon out and had checked it using radiopaque dye.It had leaked as the surgeon turned the inflation syringe.It seemed like a bond was bad where the balloon and shaft met.That's where it had leaked.The surgeon ended up doing a vertebroplasty due to not having a balloon.No patient complications were reported.There was an overall delay in the procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6192224
• MDR Text Key: 62908387
• Report Number: 2953769-2016-00090
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00613994721266
• UDI-Public: 00613994721266
• 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,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: K15B
• Device Lot Number: 0008234566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2016
• 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