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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Event Description

It was reported in retrospective analysis of prospectively collected data to compare clinical outcomes of conservative treatment with vertebroplasty, balloon kyphoplasty and the sky bone expander that a total of 62 patients (10 male, 52 female mean age 76 ± 7) were treated conservatively, 148 (24 male, 124 female mean age 77 ± 8) with vp, 97 (10 male, 87 female mean age 75 ± 11) with bk and 56(12 male, 44female mean age 75 ± 9) with sk.Oswestry disability index (odi) and short form-36 scores (sf-36) scores were also recorded at the one month and subsequently at six months and 24 months post procedure.It was reported that a total of 3 patients developed deep vein thrombosis.

Manufacturer Narrative

Literature citation:gerard wen wei ee et al."comparison of clinical outcomes and radiographic measurements in four different treatment.(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.Although it is unknown if any medtronic devices contributed to the reported event, we are filing this mdr for notification purposes.

• 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: 4922775
• MDR Text Key: 19006836
• Report Number: 1030489-2015-01481
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2015
• 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 KIT
• Patient Outcome(s): Other
• Patient Age: 00075 YR