MAUDE Adverse Event Report: MEDTRONIC MEXICO (TIJUANA) KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	K08A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent kyphoplasty at l3 due to vertebral compression fracture.Intra-op, when time came to remove balloon from vertebral body the balloon would not deflate.The surgeon deflated the balloon using a long needle to puncture balloon.When the surgeon attempted to remove the balloon, part between radiopaque markers broke off from the shaft of the balloon leaving that part in vertebral body.The surgeon proceeded to stabilize body with cement.The procedure was successfully completed with the original product.As per the surgeon, the patient was ok after the procedure.
Additional Manufacturer Narrative
Visual examination of the ibt confirmed the expandable balloon has been pulled away from the tube/shaft on the ibt and the other still has the balloon attached.It appears the tube/shaft the ibt has been cut in half due to some complications during surgery.Product cannot be functionally tested/analyzed in the returned state.The root cause of failure and damage is unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO (TIJUANA); avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc TN 22570 ; MX 22570
• MDR Report Key: 7640503
• Report Number: 1030489-2018-00912
• Device Sequence Number: 2435197
• Product Code: HRX
• UDI-Device Identifier: 00858196001154
• UDI-Public: 00858196001154
• 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): 12/10/2018

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: K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 12/10/2018
• 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: 68 YR