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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: zhi-yong sun, xue-feng li, huan zhao, jun lin, zhong-lai qian, zhi-ming zhang, hui-lin yang; "percutaneous balloon kyphoplasty in treatment of painful osteoporotic occult vertebral fracture: a retrospective study of 89 cases" a2: mean age: 67.5±11.5 ( range: 56-79 years) 55 female and 34 male (b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that between 2011 and 2013, 89 patients suffering from painful oovfs( occult osteoporotic vertebral fractures) underwent 142 percutaneous balloon kyphoplasty (pkp) procedures.Outcome data (mean variation of anterior and middle vertebral body height, visual analog scale [vas] scores, oswestry disability index [odi] scores, and sf-36 scores) were recorded preoperatively, postoperatively, and at 1 month, 6 months, and 2 year after treatment, to evaluate the results.We successfully treated 89 patients (142 vertebral bodies) with pkp.The mean variation of anterior and middle vertebral body height changed from 96.5±3.4% preoperatively to 97.2±2.5% postoperatively (p>0.05) and from 96.3±2.8% preoperatively to 97.9±3.1% postoperatively (p>0.05), respectively.The mean vas scores were reduced significantly from pre-surgery to post-surgery (8.3±1.2 to 2.9±0.7; p<(><<)>0.05), as was the odi score (76.4±12.5 to 26.7±5.6; p<(><<)>0.05).The sf-36 scores, including bodily pain (bf), vitality (vt), physical function (pf), and social functioning (sf), all showed notable improvement (p<(><<)>0.05).These variations were maintained during the 2-year follow-up perio d.Hence, pkp is a safe and effective method in the treatment of painful oovfs.Post-operatively 3 adjacent vertebral fractures developed which were associated with cement leakage nearby.

• 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: 6773043
• MDR Text Key: 82007752
• Report Number: 1030489-2017-01873
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• 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: 07/12/2017
• 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 Outcome(s): Other
• Patient Age: 67 YR