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

Catalog Number	K15B
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray review: post op kyphoplasty images for l4/5 kyphoplasty provided.Balloon markers are present in l5 owing to balloon rupture.No information is provided about expansion pressure.Balloon can be ruptured if over inflated past instructions for use(ifu) recommended pressure or if pulled back against "pac" needle.Root cause: surgical technique.
Event or Problem Description
It was reported that on (b)(6) 2016 the patient underwent kyphoplasty at l-5.Intra-op, the balloon popped during inflation.While pulling the balloon out, some part of it remained inside the vertebral body.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis:the reported complaint of a balloon rupture was confirmed during product evaluation.A radial tear was observed near the proximal 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.
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: 6184482
• Report Number: 2953769-2016-00089
• Device Sequence Number: 10946420
• Product Code: HRX
• UDI-Device Identifier: 00643169103092
• UDI-Public: 00643169103092
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2017

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 Catalogue Number: K15B
• Device Lot Number: 0007856652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2016
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided; 01/09/2017
• Initial Report FDA Received Date: 12/18/2016
• Supplement Report FDA Received Date: 02/03/2017; 09/27/2017
• 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 Age: 88 YR