MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG TSRH SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Vertigo (2134); Weakness (2145); Stenosis (2263); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Devices of multiple part numbers were implanted during the procedure including: part: 83565409; qty: 1.Part: 83565459; qty: 5.Part: 83575409; qty: 2.Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2013: the patient presented with pre-op diagnosis of low back pain.For which, patient underwent posterior lumbar spinal fusion surgery x3, posterior lumbar decompression and fusion at l3-4, l4-5 and l5-s1.On (b)(6) 2014: patient underwent mri of lumbar spine with and without contrast due to lumbago.Impression: at l2-3, there is right-sided neural foraminal encroachment and mild concentric spinal stenosis.At l3-4, there is concentric spinal stenosis with postoperative and osteoarthritic changes.At l4-5, there is a soft tissue density extending into the right neural foramina which enhances with gadavist injection and is consistent with epidural fibrosis.Enhancement adjacent to the thecal sac and extending into the neuro foramina, without specific soft tissue density, in the areas of previous surgery as above.Postoperative changes of the lumbar spine as above.On (b)(6) 2015: patient presented for an evaluation of his lumbar spine with complaint of severe back pain and right thigh numbness and weakness.On (b)(6) 2015: patient presented for follow-up after her lumbar ct myelogram and also had an l2-l3 injection which gave him 2 weeks of 100% relief.On (b)(6) 2015: patient underwent a partial laminectomy procedure.On (b)(6) 2015: patient presented for follow-up after having partial laminectomy at l2-3 done on (b)(6) 2015, with complaints of worsening pain and weakness in the right leg with global weakness.On (b)(6) 2015: patient presented with continuing weakness with ambulation.On (b)(6) 2015: patient presented for follow-up with having extremely debilitating pain that is on right side at the lumbosacral junction.Patient was provided injections for pain relief.On (b)(6) 2015: patient presented for pre-anesthesia testing for removal of lumbar hardware.On (b)(6) 2015: patient presented with following pre-op diagnoses: low back pain; bilateral s1 screw loosening; symptoms failed non-operative treatment as well as prior surgical intervention.Status post posterior spinal fusion with instrumentation at l3-4, l4-5, l5-s1; bilateral pedicle screws and rods.For which the findings were: there were loose screws at s1 but there was a voluminous amount of bone that had formed over the screws, especially on the left side.Per op notes, the appropriate screw drivers were used to remove the crosslink adaptor followed by the set screws and then the rod and the connectors.Of note, the rod on the left side was broken at the level of the crosslink adaptor.Once all instrumentation was removed.The pedicles were stressed to evaluate the facets stressed at l5-s1 level.Joy sticks were placed into the pedicles on the left at l5 and s1 and the facet stressed as well as the level.The fusion appeared to be solid.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2015: patient presented for 2 week follow-up "s/p roi l-3 on (b)(6) 2015".Assessment: lumbar radiculopathy; mechanical complication of internal orthopedic device, implant and/or graft (bilateral s1 screw loosening, other mechanical complication of other internal orthopedic device, implant and graft); low back pain.On (b)(6) 2015: patient presented for follow-up "s/p roi l-3 on (b)(6) 2015: patient presented with complaint of right hip pain.Assessment: lumbar radiculopathy; hip pain.On (b)(6) 2015: patient presented for follow-up after "esi" assessment: lumbar radiculopathy; low back pain; spinal stenosis of lumbar region.On (b)(6) 2015: patient underwent an mri, which confirmed the presence of a recurrent right facet cyst that was (reportedly) the source of the recurrent pain.On (b)(6) 2015: patient presented for follow-up of lumbar spine after mri and having severe radiating right leg pain but stable.Assessment: lumbar radiculopathy; low back pain; spinal stenosis of lumbar region.On (b)(6) 2016: patient presented with following pre-op diagnoses: severe recurrent stenosis, l2-3.Sever spondylosis, l2-3; severe chronic low back and radiating right leg pain; right lower extremity radiculopathy; symptoms worse with lumbar extensions.For which, patient underwent following procedures: direct lateral interbody fusion with interbody device l2-3.Posterior spinal fusion with non segmental instrumentation, l2-3, using bilateral pedicle screw and rod technique; redo laminectomy with complete facetectomies, l2-3; intertransverse arthrodesis, l2-3; neurophysiologic monitoring.Instrumentation used: interbody device was used as well as 3dx pedicle screw and rod system; extra small bone morphogenic protein sponge kit and grafton dbf.In addition, cancellous allograft chips were used in the posterolateral gutters.Per op notes, at l2 and l3 surgeon removed the fusion mass.Bone graft gel was then placed in the posterolateral gutters bilaterally.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2016: patient presented for 2 week follow-up "s/p dlif l2-3/ psf w/instrumentation/ re-do lamy l2-3 on (b)(6) 2016: patient presented for 7 week follow-up "s/p dlif l2-3/ psf w/instrumentation/ re-do lamy l2-3 on (b)(6) 2016".

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2014 the patient was presented for office visit with new spots on the back and numbness in the knee.Assessments: hypertension; neuralgia/ radiculitis; fatigue; hypercholesterolemia; prostate screening; hypogonadism.On (b)(6) 2014 the patient was presented for office visit with back pain and numbness in the legs.Assessments: polyneuropathy in other disease; hypertension; hypogonadism; hypercholesterolemia; unspecified vitamin d deficiency and degenerative lumbosacral disc.On (b)(6) 2014 the patient was presented for office visit with cryo spots on back and chest.Assessments: actinic keratosis.On (b)(6) 2014 the patient was presented for office visit for flu vaccine.Assessments: influenza vaccination.On (b)(6) 2014, the patient presented with pre-op diagnosis of low back pain/ lumbago.Impression: at l2-3 , there is right sided neural foraminal encroachment and mild concentric spinal stenosis; at l3-4, there is concentric spinal stenosis with post-op and osteoarthritic changes.On (b)(6) 2014 the patient was presented for office visit.Assessments: hypertension, hypercholesterolemia, hypogonadism.On (b)(6) 2015 the patient was presented for office visit with back and knee issues.The patient also reported pain in lumbar and down back.Assessments: pain in the joint lower leg; lumbago.On (b)(6) 2015 the patient was presented for office visit with vertigo.Assessments: benign positional vertigo; displaced lumbar intervertebral disc.On (b)(6) 2015 , the patient presented for ct myelogram of lumbar spine.Assessment: low back pain - lumbago.Spinal stenosis at l2-3 with evidence of pedicle screw instrumentation at l3.On (b)(6) 2015 the patient was presented for office visit with legs and back pain form his spinal stenosis.Assessments: hypertension, abnormal electrocardiogram.On (b)(6) 2015, the patient presented with diagnosis of right quadriceps radlcuiopathy.Recurrent stenoels, l2-3.Status post l2-3 partial laminectomy with decompression.Possible postoperative wound infection versus hematoma.Remote history of (b)(6) infection to the cervical spine.The post op diagnosis were : recurrent stenosis, l2-3.Status post l2-3 partial laminectomy with decompression.Right quadriceps radiculopathy.Lumbar epidural hematoma.Postoperative seroma, superficial, with potential wound contaminant/infection following procedures were performed: : revision decompression, l2-3.Lumbar spine hematoma evacuation, l2-3.Lumbar spine wound exploration.Vacuum assisted closure (vac) device placement.On (b)(6) 2015 the patient was presented for office visit with little vertigo.Assessments: hypertension; drug therapy.On (b)(6) 2015 the patient was presented for office visit with little vertigo.Assessments: hypertension; drug therapy.The patient was also presented for lumbar radiculopathy- right quadriceps weakness, thoracic or lumbosacral neuritis or radiculitis.On (b)(6) 2015 the patient was presented for office visit for follow up after laminectomy done at l2-3 on (b)(6) 2015.The patient still retained the weakness during ambulation, continued right buttocks pain.Assessment: lumbar radiculopathy, mechanical complication of internal orthopedic device, implant or graft-bilateral s1 screw loosening.On (b)(6) 2015 the patient underwent ct scan of the lumbar spine due to mechanical complication of orthopaedic device.Impression: pedicle screws from l3 to l5 with laminectomies definitively l4-5 and l5-s1.There is interconnecting harrington rods; at l1-l2 there is diffuse disc bulge and facet degenerative change causing mild central stenosis; there is some luminal right sided foraminal stenosis; at l3-4 there is minimal disc bulge causing mild central stenosis.There is mild right sided foramina; stenosis; at l5-s1 there is diffuse disc bulge with a laminectomy defect and there is facet arthritis.Subtle radiolucencies around the s1 screws and appears to be fused l3-5 and questionable at l5-s1 with vacuum phenomenon at l5-s1.

Manufacturer Narrative

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

• Brand Name: TSRH SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5829065
• MDR Text Key: 50640230
• Report Number: 1030489-2016-02203
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090740
• 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: 09/14/2016

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: 06/30/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided; 09/14/2016
• Supplement Dates FDA Received: 09/28/2016; 09/24/2017
• 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 Age: 67 YR
• Patient Weight: 88