MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L DE C.V. KYPHON XPANDER INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number K09A

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

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 was pre-operatively diagnosed with vertebral compression fractures (vcf) and underwent balloon kyphoplasty (bkp) surgery.During surgery, the balloon broke.The product came in contact with the patient.A little contrast media leaked into the patient's body.The patient was not allergic to contrast media.No fragments of the balloon are remaining in the patient.No patient complications were reported.

• Brand Name: KYPHON XPANDER INFLATABLE BONE TAMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L DE C.V.; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L DE C.V.; avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8205749
• MDR Text Key: 131719390
• Report Number: 9612164-2018-03789
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00858196001161
• UDI-Public: 00858196001161
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K09A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/31/2018
• 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 Age: 81 YR