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

Catalog Number	KX203
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with vertebral compression fractures of t11 and t12, and underwent a balloon kyphoplasty surgery.Intra-operatively, during inflation, at level t12, the balloon ruptured and split into two pieces and got stuck in the patient's body.The physician gently tried to remove the pieces but did not succeed.The surgeon removed the cannula and the balloon pieces were still remaining inside the patient's body.The anterior portion of the balloon was stuck in the patient's vertebral body and a portion of the posterior part was stuck in the pedicle (as evidenced by the visibility of the marker bands on x-ray).Despite several attempts, the surgeon was unable to remove either of the two pieces from the patient's body.The surgeon then satisfactorily filled the cavity and the case was completed successfully with the fragments of balloon remaining inside patient's body.There was a delay of approximately 5-10 minutes as a result of this event and no patient complications were reported so far.
Additional Manufacturer Narrative
Product analysis: the reported complaint of a balloon rupture was confirmed during product evaluation.Visual review identified a radial tear was observed near the proximal start 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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• MDR Report Key: 6607328
• Report Number: 2953769-2017-00065
• Device Sequence Number: 606219
• Product Code: HRX
• UDI-Device Identifier: 00643169093676
• UDI-Public: 00643169093676
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• 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,Followup
• Report Date (Section B): 06/07/2017

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: KX203
• Device Lot Number: 0008148096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 06/07/2017; 06/07/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 07/05/2017; 10/04/2017
• 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: 50 YR