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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (revision surgery).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 on: (b)(6) 2013 the patient underwent a posterior lateral arthrodesis only at l2-3, l3-4, l4-5, l5-s1 removal of posterior nonsegmental hardware across the single inner space at l4-5, posterior lumbar segmental instrumentation implanted at l2, l3, l4, l5 and s1.Spinal stereotaxy, complete laminectomy with bilateral recesses l2-3, microscope, same incision bone graft harvest, single small dose of bone morphogenic protein posterolaterally for pseudoarthrosis.Hardware implanted: pedicle screw instrumentation with crosslink.Preoperative diagnosis: lumbar pseudoarthrosis following fusion l3-4 and l5-s1, severe lumbar stenosis l2-3, neurogenic claudication, bilateral flailed feet and severe neural foraminal compromise at l5-s1.As per op notes: ¿the pedicle screws at l4-5 were exposed.The inter-spinous process spacer device below the spinous process of l2 was exposed, it was floating above l3.There was no bone below the inter-spinous process spacer and it was completely removed without difficulty.¿¿¿we then decorticated the facet joints at l2-3, l3-4, l4-5, l5-s1 for our posterolateral arthrodesis at l2-3, l3-4, l4-5 and l5-s1.We then placed bone autograft and a single small dose of bmp from l2 to s1.The sacral ala had been thoroughly decorticated as well.A large amount of bony allograft had been placed.¿.

• 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: 6492862
• MDR Text Key: 73020174
• Report Number: 1030489-2017-00882
• 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: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided; 04/18/2017
• Supplement Dates FDA Received: 04/18/2017; 10/02/2017
• 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): Required Intervention