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

Catalog Number	KX203
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8959748
• Report Number: 9612164-2019-03741
• Device Sequence Number: 11455299
• Product Code: HRX
• UDI-Device Identifier: 00763000025731
• UDI-Public: 00763000025731
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: KX203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1