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

Catalog Number	K15B
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• MDR Report Key: 6192224
• Report Number: 2953769-2016-00090
• Device Sequence Number: 16270824
• Product Code: HRX
• UDI-Device Identifier: 00613994721266
• UDI-Public: 00613994721266
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: K15B
• Device Lot Number: 0008234566
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other