MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON EXPRESS INFLATABLE BONE TAMP; ARTHROSCOPE

Catalog Number	KPE1001-CDS
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Extravasation (1842)
Date of Event	08/07/2019
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 unknown spinal surgery at t7 due to hemangioma.Intra-op, cement extravasation occurred after filling the satisfactory cement due to this pulmonary embolism occurred.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Procedure performed- kyphoplasty the cement extravasation occurred intra-operatively but noticed post-operatively.The cement was stored at proper temperature(s) before and during the procedure(below 25 ° c during storage; 23 +/- 1 ° c for 24 hours prior to use).

• Brand Name: KYPHON EXPRESS INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8954887
• Report Number: 1030489-2019-00968
• Device Sequence Number: 13975189
• Product Code: HRX
• UDI-Device Identifier: 00643169456006
• UDI-Public: 00643169456006
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/12/2019

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: KPE1001-CDS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: 20 YR