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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Literature citation: bornemann, rahel; jansen, tom r; kabir, koroush; pennekamp, peter h;stuwe, brit; wirtz, dieter c; pflugmacher, robert."comparison of radiofrequency- targeted vertebral augmentation with balloon kyphoplasty for treatment of vertebral compression fractures" age at the event: mean age is 70 years sex: 116 females and 74 males.(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 the literature titled ¿comparison of radiofrequency-targeted vertebral augmentation with balloon kyphoplasty for treatment of vertebral compression fractures¿ that the safety and effectiveness of radiofrequency- targeted vertebral augmentation (rf- tva) was evaluated in comparison with balloon kyphoplasty (bk) on the basis of matched pairs.25 patients had incidence of cement leakage.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6776218
• MDR Text Key: 82127503
• Report Number: 1030489-2017-01878
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/09/2017
• 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: N
• Patient Sequence Number: 1
• Patient Age: 70 YR