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 Dysphasia (2195); Numbness (2415); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.

Event Description

The 5 patients (6 affected intervertebral spaces) who underwent surgery with interspinous vertebral spacer in and after (b)(6) 2012 were studied.Post-operative, spinous process fracture, numbness, dysphasia were confirmed as complication in one patient.

Manufacturer Narrative

Literature citation:ken sato, masato honda, souichi nakajima, yuuichi toujou, sinichirou yoshida and yutaka yabe; "results of treating lumbar spinal canal stenosis with x-stop".Age upon surgery was 60-77(mean:69).There were 4 males and 1 female.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5096766
• MDR Text Key: 26555859
• Report Number: 1030489-2015-02483
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Report Date: 08/25/2015

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00069 YR