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

Catalog Number KX203

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2019

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 presented with "bwk12" fracture and osteoporosis; and underwent balloon kyphoplasty at 1 level.Intra-op, after drilling, the surgeon cleaned the bone fragments with the bone filler as usual.But after insertion of the inflatable bone tamp through the introducer, it was not possible to inflate the balloon.The surgeon removed the balloon and detected that there was a hole in the balloon due to which the balloon could not be inflated.A new kit was then opened to complete the procedure.No delay in overall procedure time was noted.No patient complications were reported.

• Brand Name: KYPHON XPANDER II 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: 8959748
• MDR Text Key: 156464396
• Report Number: 9612164-2019-03741
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00763000025731
• UDI-Public: 00763000025731
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K101864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KX203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• 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