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

Catalog Number	K09A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device fragment in patient.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 osteoporotic spinal fracture of t12 and l1.Intra-op, the left inflatable bone tamp (ibt) of l1 inflated in a vertical snowman shape that pushed up the superior endplate.Then, the surgeon deflated it and waited for the contrast to come into the inflation syringe, but the surgeon struggled to extract it.It was noted that the wire came loose and pulled away from the back of the balloon but when he tried to push it forward, it wouldn't budge.Then surgeon pulled hard and the ibt came out but the silicone piece of the balloon was left behind in the patient's vertebral body.The balloon ruptured during deflation when the pressure was less than 200 psi and volume of rupture was 3 cc.The surgeon cemented the broken fragment of the balloon in place.Cement was injected and the procedure was completed successfully.No patient complications have been reported.
Additional Manufacturer Narrative
Product analysis: visual inspection confirmed the balloon and part of the plastic sleeve has been torn from the shaft of the ibt.It appears the ibt was damaged from the removal process.It was unable to determine root cause of ibt damage.T.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KYPHON XPANDER 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: 9175746
• Report Number: 9612164-2019-04303
• Device Sequence Number: 14120625
• Product Code: HRX
• UDI-Device Identifier: 00763000025595
• UDI-Public: 00763000025595
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 12/06/2019

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: K09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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: 69 YR
• Patient Weight: 77