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

Model Number	C01A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Extravasation (1842); Spinal Cord Injury (2432)
Date of Event	12/07/2021
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.Other: dural repair was performed.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 possible screw migration involved in the reported event.Levels implanted t10; t11.It was reported that intra-operatively, fenestrated screws with cement.Injected cement downsizes 3 bone fillers and watched on xray.Cement extravasated to spinal canal.Due to extravasation in spinal canal the dural tear was reported.Additional surgery- laminectomy done and dural repair was performed as a result of this event.There was delay in overall procedure time.There was no malfunction of the cds system during use.Cement stored at proper temperature(s) before and during the procedure.Cement mixed for 60 seconds.Procedure was completed successfully with original products.On (b)(6) 2021, received additional information that therapy was cementing screws.Unknown former screws.Added 2 hours to case.Levels cement extravasated t11 and t12.Cement extravasated at implanted level and one level below.Additional surgery/treatment-laminectomy and dural repair was performed on the same day.

• 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: 13116447
• Report Number: 1030489-2021-01599
• Device Sequence Number: 17338545
• Product Code: NDN
• UDI-Device Identifier: 00643169097865
• UDI-Public: 00643169097865
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041584
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

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: 05/31/2024
• Device Model Number: C01A
• Device Catalogue Number: C01A
• Device Lot Number: EL70228
• 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: 12/07/2021
• Initial Report FDA Received Date: 12/30/2021
• Date Device Manufactured: 06/22/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Male