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

Device Problem Fracture (1260)

Patient Problems Pain (1994); Dysphasia (2195); Numbness (2415)

Event Type  Injury  

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 (b)(6) (mean: 69).There were 4 males and 1 female.(b)(6).(b)(4).Neither the device nor applicable imaging films were returned to manufacturer therefore cause of event cannot be determined.

Event Description

It was reported that 5 patients (6 affected intervertebral spaces) who underwent surgery with interspinous vertebral spacer in and after (b)(6) 2012 in an abstract.Post-operative, spinous process fracture, pain, numbness, dysphasia and spinous process fracture is confirmed as complication in one patient.

• 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: 5096770
• MDR Text Key: 26556502
• Report Number: 1030489-2015-02485
• 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: consumer,foreign
• Reporter Occupation: Physician
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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: 08/25/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 00069 YR