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	12/30/2020
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
Information was received from healthcare professional via field representative regarding patient with compression fracture at l1 and l5 involved in kyphoplasty procedure.Levels implanted- l1 l5.It was reported that during procedure when working on the second level with a new balloon tamp, the balloon ruptured.The ibt failed during the first insertion attempt into the vertebral body.When working on second level with a new tamp, the gauge registered 237 psi and the balloon/tamp ruptured.There was no problem with the expander 1 balloon tamp.It is unknown whether the patient was allergic to the contrast media.There was no delay in overall procedure time.Procedure was completed with a new product.No additional treatment/surgery performed as a result of this event.Patient was not hospitalized prolong as a result of the event.There were no patient symptoms or complications as a result of this event.Patient is alive and no injury.

• 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: 11182927
• Report Number: 9612164-2021-00203
• Device Sequence Number: 14292949
• 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): 01/17/2021

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: 04/28/2022
• Device Model Number: KPX153AB
• Device Catalogue Number: KPX153AB
• Device Lot Number: 220866365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR