MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHX® HV-R¿ BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number	CX01A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	10/11/2021
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
Information was received from a hcp via clinical study regarding a patient with clinical id:(b)(6).Clinical study number: (b)(6).Patient medical history: hypertension; osteoporosis; osteopenia; gastrointestinal; chronic gastritis; it was reported that on (b)(6) 2021, the patient went to h hospital for 6-month x-ray examination, which revealed bone cement exudation.Outcome: recovering/resolving  investigator assessment: is this ae related to a study procedure: not related; is the ae related to the bone cement: probable; is the ae related to any other components used during the procedure: possible; is the ae related to an underlying condition or disease: possible; what was the rationale for the relationship to system or procedure: not related.Sponsor assessment: probable related to bone cement; possible related to underlying condition; not related to procedure, other components.Outcome: recovering/resolving  there were no further complications reported regarding the event.Updated information received on 21-oct-2021: ae description: on (b)(6) 2021, the patient went to hunan provincial people's hospital for 6-month x-ray examination, which rev ealed bone cement exudation.No statements in the ae.; is the ae related to any other components used during the procedure: not related; what was the rationale for the relationship to system or procedure: the extravasation was related to the fracture fissure high liquid/solid ratio of the mixed bone cement, short solidification time and high presure of the cavity.
Event or Problem Description
Information was received from a hcp via clinical study regarding a patient with clinical id:(b)(6).Clinical study number: (b)(4).Patient medical history: hypertension; osteoporosis; osteopenia; gastrointestinal; chronic gastritis; it was reported that on (b)(6) 2021, the patient went to (b)(6) hospital for 6-month x-ray examination, which revealed bone cement exudation.Outcome: recovering/resolving  investigator assessment: is this ae related to a study procedure: not related; is the ae related to the bone cement: probable; is the ae related to any other components used during the procedure: possible; is the ae related to an underlying condition or disease: possible; what was the rationale for the relationship to system or procedure: not related.Sponsor assessment: probable related to bone cement; possible related to underlying condition; not related to procedure, other components.Outcome: recovering/resolving  there were no further complications reported regarding the event.Updated information received on 21-oct-2021: ae description: on (b)(6) 2021, the patient went to (b)(6) hospital for 6-month x-ray examination, which revealed bone cement exudation.No statements in the ae.; is the ae related to any other components used during the procedure: not related; what was the rationale for the relationship to system or procedure: the extravasation was related to the fracture fissure high liquid/solid ratio of the mixed bone cement, short solidification time and high presure of the cavity.
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.

• Brand Name: KYPHX® HV-R¿ BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• 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: 12777528
• Report Number: 1030489-2021-01356
• Device Sequence Number: 5749469
• Product Code: NDN
• UDI-Device Identifier: 00643169097803
• UDI-Public: 00643169097803
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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 Expiration Date: 06/30/2022
• Device Model Number: CX01A
• Device Catalogue Number: CX01A
• Device Lot Number: EL70141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/09/2021
• Date Device Manufactured: 08/20/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 51 KG