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

Catalog Number 1-3212

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

It was reported that the patient underwent interspinous spacer surgery for lcs.Confirming x ray image post-op, the surgeon noticed the cranial wing of the universal wing assembly went over inter spinous ligaments and moved to the right side.The concerned wing was removed and placed in revision surgery.The surgical time was extended for about 30 -60 minutes.The product used in the patient.No patient complications were reported.The interspinous spacer (size 12) was inserted after expanding with trial 14.Universal wing assemble was placed and completed the initial surgery.After changing a position of the patient, x-ray found that wing part was tilted and cranial part went through inter spinous ligaments.The revision surgery was operated on same date to re position the interspinous spacer.The surgeon told that it might be dislocated at time of the position change immediately after the surgery.

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• 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: 5080099
• MDR Text Key: 25993651
• Report Number: 1030489-2015-02388
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2016
• Device Catalogue Number: 1-3212
• Device Lot Number: RM14G011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2015
• Initial Date FDA Received: 09/16/2015
• 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): Required Intervention
• Patient Age: 00084 YR
• Patient Weight: 62