MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	KE152
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.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 t12 fracture and underwent balloon kyphoplasty (bkp) surgery.During surgery, the balloon ruptured and was very difficult in removing from vertebral body.The pressure prior to rupture was 275 mm hg and volume prior to rupture was 3ml.No piece of the balloon remained in the patient.The product came in contact with the patient.No health damage to patient has been reported.
Additional Manufacturer Narrative
Additional information: product analysis: visual and functional inspection confirmed the ibt has been damaged.The ibt was returned inside the used cannula and unable to be pulled back through the cannula due to the state of the balloon.It appears the balloon was ruptured and is consistent with possible contact with sharp object, such as bone splinters while being fully inflated at the time of contact.The root cause of this damage is undetermined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L DE C.V.; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7959536
• Report Number: 9612164-2018-02719
• Device Sequence Number: 201971
• Product Code: HRX
• UDI-Device Identifier: 00643169143777
• UDI-Public: 00643169143777
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K123771
• 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): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: KE152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR