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

Catalog Number	C01A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Collapse (2416)
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
Pre-operative diagnosis for this procedure: primary osteoporosis type of fracture: compression fracture levels implanted: t11-l5 it was reported that the patient underwent a kyphoplasty at l1, l3.Post-op, collapse occurred at l1 and patient experienced neurological symptoms due to osteophyte invagination into the spinal canal.Hence, posterior fusion was performed as a result of the event.

• 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
• MDR Report Key: 8244747
• Report Number: 1030489-2019-00050
• Device Sequence Number: 2701652
• Product Code: NDN
• UDI-Device Identifier: 00643169097865
• UDI-Public: 00643169097865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: C01A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/14/2019
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75