MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHON 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 Code	Inadequate Pain Relief (2388)
Date of Event	08/15/2011
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Primary diagnosis: primary osteoporosis levels implanted: t12 type of fracture: compression fracture date of admission: (b)(6) 2011 date of discharge: (b)(6) 2011 it was reported that patient fell down the stairs and was injured.Synostosis can not be obtained with inpatient rest for more than 1 month and balloon kyphoplasty is enforced for symptom exacerbation.Hospitalization period became longer than usual.Post op remaining nrs score was reported.

• Brand Name: KYPHON HV-R BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• MDR Report Key: 6757952
• Report Number: 2953769-2017-00088
• Device Sequence Number: 13825748
• Product Code: NDN
• UDI-Device Identifier: 00613994583215
• UDI-Public: 00613994583215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2017

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 Expiration Date: 09/30/2013
• Device Catalogue Number: C01A
• Device Lot Number: EL35410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/01/2017
• 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: 81 YR
• Patient Weight: 53