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

Catalog Number K08A

Device Problem Deflation Problem (1149)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/01/2018

Event Type  Injury  

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 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.

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
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO (TIJUANA); avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc TN 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO (TIJUANA); avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc TN 22570 ; MX 22570
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7640503
• MDR Text Key: 112410551
• Report Number: 1030489-2018-00912
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00858196001154
• UDI-Public: 00858196001154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR