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

Catalog Number	K15B
Medical Device Problem Codes	Inflation Problem (1310); Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
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 underwent unknown surgery at l1-l2 due to 2 level compression fracture.Intra-op, the balloon would not expand initially because the band on the proximal portion of the balloon that has the size of the kit on it (15/2) was loose.It slides up and down shaft of the balloon and could accidentally be implanted in the patient.It was not noticed and the balloon went up to 700 psi.Later it slipped out of the band and expanded rapidly.There was delay in overall procedure time and the procedure was successfully completed with the original product.There were no patient symptoms or complication reported as a result of this event.

• Brand Name: KYPHON EXPRESS 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: 9517651
• Report Number: 9612164-2019-05295
• Device Sequence Number: 13546791
• Product Code: HRX
• UDI-Device Identifier: 00763000025625
• UDI-Public: 00763000025625
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K041454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/25/2019

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: K15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1