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

Model Number	KPX153AB
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider via manufacturing representative regarding patient with compression fracture at t11 and l1 suggested for spinal therapy.It was reported surgeon stated the bone was hard.He completed inflation with other balloon tamp in kit with no problem.Rupture occurred during inflation.No patient symptoms reported.Customer discarded the device.

• 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: 11647759
• Report Number: 9612164-2021-01409
• Device Sequence Number: 14373337
• Product Code: HRX
• UDI-Device Identifier: 00763000026998
• UDI-Public: 00763000026998
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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 Expiration Date: 07/27/2022
• Device Model Number: KPX153AB
• Device Catalogue Number: KPX153AB
• Device Lot Number: 221016801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1