MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; CEMENT, BONE, VERTEBROPLASTY

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported in a literature article that patient had persistent back pain due to non-union after l1 vertebral compression fracture.Patient underwent balloon kyphoplasty,and achieved restoration of vertebral body height immediately after the procedure.At four weeks after the procedure, however, patient developed anterior migration of cement, resulting in progression of local kyphosis.Anterior deviation of c7 plumb line was 11.9 cm immediately after the procedure, which deteriorated to 20.0 cm due to anterior dislodgement of cement.

Manufacturer Narrative

Literature citation: masahiro kanayama , fumihiro oha, akira iwata, tomoyuki hashimoto."does balloon kyphoplasty improve the global spinal alignment in osteoporotic vertebral fracture?".(b)(4).Hcp medical judgment "this pe involves a japanese a case study regarding bkp improving sagittal spinal alignment.In this case a (b)(6) patient with end stage spinal disease and multiple fractures underwent kyphoplasty at l1.Present also is a vertebral plana fracture at l3 and a wedge fracture at t12.In the ensuing radiographs, the t12 fracture has worsened, there is a new compression fracture at l2 and the cement and vertebral body of the index l1 have disassociated with the posterior elements and migrated ventrally.Collectively these changes have caused a worsening of the local kyphosis.The case is reportable due to subsequent fracture and disassociation of the index l1 level.".

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4962566
• MDR Text Key: 6034824
• Report Number: 1030489-2015-01877
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BKP
• Patient Outcome(s): Other
• Patient Age: 00077 YR