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

Model Number	KPX103PB-CDS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Dyspnea (1816); Extravasation (1842)
Date of Event	10/27/2021
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.Outcomes attributed to adverse event: other: pulmonary embolism.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 pre-op diagnosis- compression fracture l1, l2 involved in kyphoplasty procedure.Levels implanted- l1, l2.It was reported that intra-operatively, kyphoplasty procedure was performed on (b)(6) 2021 at level l1, l2.While injecting cement a ppeared to be extravasated, they stopped injecting at that point and completed procedure.Cement was stored at proper temperature(s) before and during the procedure.Cement was mixed approximately for 1minute 30 seconds.Cement was doughy and homogenous prior to delivery into the patient.On (b)(6) 2021, patient went to emergency department either over weekend or earlier of the week and imaging detected pulmonary embolism.Patient had a coughing event during case prior to any cement being injected.Mac anesthesia was used for case.On 2021-nov-19, received additional information that cement appeared to extravasated away from treated level (appeared lateral to vertebral body and moved away).Doctor believed cement caused pulmonary embolism.No plan for revision surgery.Patient was not hospitalized prolong.Patient status was okay and mildly short of breath but tolerable.

• Brand Name: KYPHON XPANDER¿ II INFLATABLE BONE TAMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12890019
• Report Number: 1030489-2021-01475
• Device Sequence Number: 4364420
• Product Code: HRX
• UDI-Device Identifier: 00643169671720
• UDI-Public: 00643169671720
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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 Expiration Date: 03/03/2022
• Device Model Number: KPX103PB-CDS
• Device Catalogue Number: KPX103PB-CDS
• Device Lot Number: 0222080344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/30/2021
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female