MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CAPSTONE VERTEBRAL BODY SPACER

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2007: patient presented with preoperative diagnosis of l5-s1 discogenic back pain and stenosis, intractable back and lower extremity pain and underwent following procedures: right sided l5-s1 tlif, placement of inter body device at l5-s1,posterior segmental instrumentation with bilateral percutaneous pedicle screws at l5-s1 and psf(l5-s1).Indications: the patient has had problems with her back and lower extremities for several years.Her symptoms produce a gait disturbance.Diagnostic studies included x-rays, mri and discograms.The x-rays and mri show essentially a one level pattern of disc degeneration at l5-s1.There is a centralized bulging resulting in stenosis.She also has an obvious annular tear on the mri.Discograms revealed markedly concordant pain at l5-s1 with a grade 4 posterior annular tear.The l3-4 and l4-5 discs produced mildly concordant pain at l3-4 only, but both had normal morphology on post discogram ct.Per operative notes: the pedicle screws were inserted on the left side into the l5 and s1 pedicles.After insertion of the screws the rod inserting device was placed on the top of the screw housings.An appropriately sized rod was selected and then inserted through the screws.Next, transforaminal lumbar inter body fusion was performed.The annulus of l5-s1 disc was exposed by retracting the dura medially and protecting the exiting nerve root.Annulotomy was performed.The disc was removed with a combination of pituitary and curettes.Distraction was held by tightening the set screw of the left l5 pedicle screw.Upon completion of the discectomy, sizing of the interbody device was performed and the appropriately sized inter body device was selected.Local autologous bone was packed anteriorly in the disc space followed by a pledget of bmp.The 14 x 32 millimeter device was then inserted, which had been filled with bmp along with some more local bone auto graft.The right sided screws were then inserted using c-arm guidance.The patient was awakened in the or and transported to the recovery room in stable condition.No patient complications were reported.On (b)(6) 2009: patient presented with pre-operative diagnosis of l5-s1 pseudoarthrosis and intractable low back pain and underwent following procedures: removal of inter body cage l5-s1 via left lower quadrant retroperitoneal approach and partial corpectomy of l5, insertion of intervertebral biomechanical device at l5-s1, removal and replacement of bilateral l5 and s1 pedicle screws and rods, exploration of fusion l5-s1 and psf l5-s1.Indications: patient has had problems with her back and lower extremities for several years.She underwent an l5-s1 mast/tlif in (b)(6) 2007.Post op, pain returned which worsened and continues to be significantly symptomatic.Her symptoms produced a gait disturbance.Diagnostic studies included x-rays ,ct and discogram.The x-rays and ct showed good placement of the pedicle screws at l5 and s1 bilaterally.There is no robust amount of bone formation posteriorly or in the inter body space.Discogram revealed concordant pain at l5-s1 again with no robust bone formation in the interspace.The l4-5 level was relatively asymptomatic.Per op notes: after exposure was obtained at the l5-s1 interspace, annulotomy was made with a combination of bovie and ¿# 10 blade.¿ the anterior annulus was resected.The cage was identified and grossly loose confirming pseudoarthrosis.Distraction maneuvers were also performed which show clear pseudoarthrosis at l5-s1.There was some subsidence and the cage had eroded through the inferior endplate of l5 and into the lower aspect of the l5 vertebral body.In order to remove the cage, partial corpectomy was required with an osteotome.The space was trialed and a size 20 x 12 graft was selected.The graft was filled with half a large bmp sponge and corticocancellous allograft.The implant was then inserted.There was excellent press-fit of the graft.Upon completion of anterior portion of procedure, the patient was placed prone and dissection was carried down to the posterior instrumentation.All screws were evaluated for their purchase and all four pedicle screws were loose and removed.A larger diameter (7.5 mm) pedicle screw was then inserted bilaterally at l5 and s1.On the right side, tissue was debrided to expose the right l5 transverse process and sacral ala.These were decorticated and posterolateral graft was placed.This consisted of some bmp along with allograft chips and auto graft taken from the anterior vertebral body.On the left side, posterior elements were intact and graft was placed, consisting of bmp and allograft.The patient was turned supine, awakened in the or, transported to recovery room in stable condition.No complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE VERTEBRAL BODY SPACER
• 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: 5537479
• MDR Text Key: 41522859
• Report Number: 1030489-2016-00867
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

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: 03/07/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: 03/07/2016
• Supplement Dates FDA Received: 09/20/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention