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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Literature citation: sano h, ichimura m, hasegawa m, takahashi m, hasegawa a.¿the evaluation of new vertebral fracture after balloon kyphoplasty¿.The mean age of patients: 78 years, 14 males, 27 females.(b)(6).(b)(4).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.

Event Description

It was reported in an abstract that total of 41 patients underwent balloon kyphoplasty procedure (bkp) from sep 2011 to aug 2014 in the hospital.There were 14 male and 27 female with mean age of 78 years old (59-92 years old).The indication for bkp in hospital was set in the case of intravertebral cleft after chronic compression fracture, and the case with bulge of the posterior vertebral wall without nerve palsy, in addition to the patients of osteoporosis with persistent pain after receiving sufficient conservative therapy accordance with the act.The mean surgical duration was 68.5 min (47 to 105 min), the mean cement insertion volume was 5.5 ml (4.0 to 8.5 ml).It was reported that cement migration was observed in 5 cases.The type/manufacturer of cement used in this study was not specified in the article.

Manufacturer Narrative

(b)(4).

• 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: 5238341
• MDR Text Key: 31977184
• Report Number: 1030489-2015-03081
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• 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: 10/21/2015
• 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
• Patient Age: 00078 YR