MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 55840006550

Device Problem Break (1069)

Patient Problems Neuropathy (1983); Pain (1994); Weakness (2145); Tingling (2171); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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 spinal surgery for the treatment of lytic spondylolisthesis (l5-s1) and back pain.At the surgery, the doctor inserted screws in order to correct the affected disk.The screw used during the procedure was titanium implant screws.Post-operatively, on an unknown date, the patient discovered that the titanium screws installed in her lower back broke in half.Reportedly, the patient suffered severe pain and lack of mobility that limited her everyday activities.On an unknown date, revision surgery was performed in order to remove the screws and prevent further damage to her spine.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: x-ray review- post-op/pre-op/post-revision images provided for l5-s1 posterolateral fusion for grade 2 spondylolisthesis.Initial hardware placement appears appropriate, there was early failure of the construct with s1 screw fracture.There was no reduction of the deformity initially.Failure happened before fusion could be expected.The hardware used (6.5 mm) may be undersized, but the pedicles are small.This was poised to an interbody construct with an anterior plate.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2015: patient presented for follow-up.Patient was having difficulty walking or climbing stairs.On (b)(6) 2015: patient is having back pain and difficulty walking or climbing stairs.

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2014: pre-op diagnosis: l5 bilateral spondylolysis.Back pain.Grade ii spondylolisthesis of l5-s1.Procedures: bilateral segmental instrumentation from l5 through sacrum.Posterior spinal fusion, l5 through sacrum.Harvesting of iliac crest bone graft through a separate incision.Use of iliac crest bone graft and fresh frozen allograft bone for fusion.As per op-notes: longitudinal incision was made dissecting down between l5 and s1.At l5 6.5mm diameter x 55 mm length screws were found to be fitting.At s1 6.5mm diameter x 50 mm length screws were found to be fitting.No patient complications were reported.On (b)(6) 2014: patient underwent rad lumbar spine ap/ lateral views.Impression: interval l5-s1 posterior spinal fusion without complication.Malalignment improved.On (b)(6) 2014: patient underwent rad lumbar spine ap/ lateral views.Impression: unchanged appearance of l5-s1 posterior spinal fusion.No alignment changes.On (b)(6) 2015: patient presented for follow-up.Patient underwent ap, lateral and coned down views of lumbar spine.Impression: status post posterior rod and pedicle screw fixation of l5-s1.Stable grade 1 anterolisthesis.No evidence of hardware loosening or failure.On (b)(6) 2015: patient presented for follow-up.X-rays showed screws have broken bilaterally at s1.On (b)(6) 2015: patient underwent ap, lateral and coned down views of the lumbar spine.Impression: both of the screws in s1 have fractured at the level of the posterior cortex.The degree of anterolisthesis of l5 on s1 appears to have increased as a result.On (b)(6) 2015: patient underwent ct of lumbar spine without contrast.Impression: s1 screw fractures better demonstrated radiographically.Moderate bilateral formainal narrowing at l5-s1 with encroachment upon both exiting l5 nerve roots.Potential small moderate sized posterior protrusion at l4-l5.On (b)(6) 2015: patient presented for follow-up.Diagnosis: implant failure of sacral screws.On (b)(6) 2015: patient presented with chief complaint of pain, weakness and tingling.Patient had fusion in (b)(6) 2014 which failed and screws came loose.A new fusion is scheduled.Ros: musculoskeletal: positive for back pain and walking difficulty.Initial diagnosis: lumbago, thoracic or lumbosacral neuritis or radiculitis, radiculopathy(lumbar region), low back pain (b)(6) 2015: patient underwent mri lumbar spine wo ivc.Impression: lumbar spine degenerative disc disease and facet joint arthropathy the findings most pronounced at l4-5 level, there is mild encroachment upon bilateral descending l5 nerve roots in subarticular recesses.Fixated l5-s1 grade ii spondylolisthesis with improved encroachment upon bilateral l5 exiting nerves.On (b)(6) 2015: patient presented with balance and gait difficulties.Ros: musculoskeletal: positive for back pain and walking difficulty.On (b)(6) 2015: patient presented for office visit.Initial diagnosis: lumbago, thoracic or lumbosacral neuritis or radiculitis, radicu lopathy(lumbar region), low back pain.On (b)(6) 2015: patient presented for office visit with pain and weakness.Ros: musculoskeletal: positive for back pain and walking difficulty.On (b)(6) 2016: pre-op diagnosis: grade 2 isthmic spondylolisthesis, l5-s1.Previous attempted posterior lateral fusion with pseudoarthrosis and failed broken s1 pedicle screw bilaterally.Bilateral l5-s1 foraminal stenosis with radiculopathy.Procedure: revision non segmental spinal pedicle screw instrumentation, l5-s1 with removal of previous broken pedicle screws in s1 and replacement of all 4 screws, l5-s1 bilaterally.Placement of 11mm height interbody spacer into l5-s1 disk space filled with bmp for interbody fusion.Botox buttress plate from the inferior aspect of l5.Decompressive bilateral foraminotomies with l5 nerve root decompressions.Posterolateral fusion, posterolateral technique on the left l5-s1.As per op-notes: at right s1, screw was removed and was noted to be broken and it was replaced by screw of similar diameter.The screw was not causing any compression medially.L5-s1 disk space was identified, endplates were prepared for fusion while bony curettes as well as bone rasp and then 11mm spacer was filled with appropriate amount of bmp soaked collagen sponge.No patient complications were reported.On (b)(6) 2016: patient presented with chief complaint of lumbar pain in the surgical area.Ros: musculoskeletal: positive for back pain and walking difficulty.Patient underwent x-ray spine, lumbar ap and lateral.Patient underwent incisional exam.Operative findings: bilateral foraminotomies sites at l5-s1.Posterior pedicle screws at l5 and s1 are intact with no evidence of failure.Anterior interbody spacer at l5-s1 is well positioned with anterior buttress plate inferior from l5.Reduction in spondylolisthesis with improvement in l5-s1 disc space.On (b)(6) 2016: patient presented for follow-up visit.Ros: musculoskeletal: positive for back pain and walking difficulty.Patient underwent x-ray spine, lumbar, apand lat.Ap view revealed grossly normal alignment with no significant obliquity.Bilateral hip joint spaces are adequately maintained.No evidence of hardware failure or migration.L4-5 disc space is adequately maintained.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 5744372
• MDR Text Key: 48006931
• Report Number: 1030489-2016-01875
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113174
• 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,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55840006550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• 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
• Patient Weight: 77