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

Catalog Number	KX203
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Hematoma (1884); Blood Loss (2597)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
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 balloon kyphoplasty due to vertebral compression fracture at l1.Intra-op, the balloon ruptured on the right side of l1.The balloon was deflated successfully.Blood began pulsating out of the right cannula.Then, balloon on left was deflated and inserted into the right cannula and inflated.Now, blood began pulsating out of left cannula as well.The surgeon decided to inject surgiflow down both cannulas.Bleeding stopped at this time.Both the balloons were inflated once more.Finally, about 7.5 cc of cement was injected into l1 successfully.A 300 ml of blood was lost due to this event.Ct conducted after the surgery revealed a small psoas hematoma.The patient is stable and is recovering from hematoma.

• Brand Name: KYPHON XPANDER II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO (TIJUANA); avenida paseo cucapah # 10510; parque industrial ei lago; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7801504
• Report Number: 9612164-2018-02110
• Device Sequence Number: 2488952
• Product Code: HXG
• UDI-Device Identifier: 00643169093676
• UDI-Public: 00643169093676
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• 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): 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/26/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR