MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK X-STOP INTERSPINOUS SPACER SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Bone Fracture(s) (1870); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Stenosis (2263); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The event details listed below have been obtained from the cer (clinical evaluation report) "(b)(4)- cer for interspinous process devices- rev- 03 mar 2017" conducted from a data set from 2009 to 2015 which contained a multi literature article review.This could contain duplicated information obtained from other literature article.The complications associated with the ipds observed during review of literature articles published in different years as reported in the cer could be summarized as below: spinous process fracture was observed in 38 cases, revision surgery due to spinous process fracture in 10 cases, hematoma in 4 cases, wound infection in 18 cases, device removal/revision surgery in 100 cases, csf (cerebro-spinal fluid) leakage in 18 cases , new level stenosis in 1 case, pain (lss-lumbar spinal stenosis symptoms, back pain, leg pain) in 86 cases, revision surgery and device removal due to worsening pain in 1 case, revision suregry and device removal due to lack of improvement/ recurrence/persistence of symptoms in 20 cases and adjacent level fracture/fracture in 17 cases.

• Brand Name: X-STOP INTERSPINOUS SPACER SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• 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: 7369308
• MDR Text Key: 103424988
• Report Number: 1030489-2018-00448
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/26/2018
• 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): Required Intervention