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

Catalog Number K09A

Device Problem Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

Device fragment in patient.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 osteoporotic spinal fracture of t12 and l1.Intra-op, the left inflatable bone tamp (ibt) of l1 inflated in a vertical snowman shape that pushed up the superior endplate.Then, the surgeon deflated it and waited for the contrast to come into the inflation syringe, but the surgeon struggled to extract it.It was noted that the wire came loose and pulled away from the back of the balloon but when he tried to push it forward, it wouldn't budge.Then surgeon pulled hard and the ibt came out but the silicone piece of the balloon was left behind in the patient's vertebral body.The balloon ruptured during deflation when the pressure was less than 200 psi and volume of rupture was 3 cc.The surgeon cemented the broken fragment of the balloon in place.Cement was injected and the procedure was completed successfully.No patient complications have been reported.

Manufacturer Narrative

Product analysis: visual inspection confirmed the balloon and part of the plastic sleeve has been torn from the shaft of the ibt.It appears the ibt was damaged from the removal process.It was unable to determine root cause of ibt damage.T.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; 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: 9175746
• MDR Text Key: 162622375
• Report Number: 9612164-2019-04303
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00763000025595
• UDI-Public: 00763000025595
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• 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: 69 YR
• Patient Weight: 77