MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON EXPRESS INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number K15B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent balloon kyphoplasty due to compression fracture.Intra-op, when the physician deflated the inflatable bone tamp (ibt) and was removing it, the balloon portion detached from the ibt.The balloon portion remained in the vertebral body.No patient complications have been reported.

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8887333
• MDR Text Key: 154102485
• Report Number: 9612164-2019-03366
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00763000025625
• UDI-Public: 00763000025625
• 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
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• 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