MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK KYPHON EXPRESS II INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number KE152

Device Problem Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

The device was not 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 l1 due to vertebral compression fracture.Intra-op, balloon ruptured and the marker got separated and was left in the vertebral body.The procedure was completed successfully with the original product.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.X-ray review: post-op x-rays for l1 kyphoplasty show a retained balloon marker.Balloon rupture can occur as a result of inflation over rated pressure or volume, or withdrawing a partially inflated balloon against the pedicle access needle.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON EXPRESS II INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7624839
• MDR Text Key: 111858810
• Report Number: 1030489-2018-00879
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00643169143777
• UDI-Public: 00643169143777
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123771
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KE152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 80 YR
• Patient Weight: 89