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

Catalog Number	K15A
Medical Device Problem Codes	Disassembly (1168); Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray image review: intra-op image provided for a two level balloon kyphoplasty.Reported levels ate t11/t12.Balloon fragments are observed in the superior level.Cement is present in both levels.Causes of balloon rupture can include inflation beyond burst pressure and withdrawing partially inflated balloon against pedicle access cannula.Root cause is most likely surgical technique.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) 2017, patient underwent balloon kyphoplasty at t11 and t12 for metastatic disease with fracture.Intr a-op, the balloon ruptured during deflation <(>&<)> came off the tamp.The product came in contact with the patient.Ruptured balloon remained inside the patient's t11 vertebral body.No patient complications were reported due to this event.
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: 6295381
• Report Number: 2953769-2017-00006
• Device Sequence Number: 13743155
• Product Code: HRX
• UDI-Device Identifier: 00858196001185
• UDI-Public: 00858196001185
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/06/2017

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: 10/21/2018
• Device Catalogue Number: K15A
• Device Lot Number: 0008347098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 02/02/2017
• 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
• Patient Weight: 73