MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Numbness (2415); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

It was reported that the patient sustained unspecified injuries following the use of rhbmp-2/acs in an unspecified spinal fusion surgery.No additional information was reported.

Event Description

It was reported that on (b)(6) 2008: the patient presented with pre-op diagnosis of spondylolisthesis with stenosis l4-5.Patient underwent posterolateral intertransverse fusion, l4-5 using lanx pedicular instrumentation and local bone graft as well as rhbmp-2/acs.Per-op notes, patient had lower extremity symptoms unrelieved by conservative care.Ct myelogram demonstrated severe stenosis with complete myelographic block at l4-5 and she had a mobile spondylolisthesis at that level.An attempt was made to open the disk space to allow insertion of the zimmer bak instruments.The disk was too collapsed and this was aborted.At this point the outer portion of the facets, the pars interarticularis and the transverse processes were completely decorticated bilaterally.The local bone graft was morselized and the pedicles instrumented.The rods were inserted and copious irrigation was done.After this bone graft was packed along the intertransverse membrane between the transverse processes bilaterally.This was supplemented with rhbmp-2/acs bilaterally.No patient complications were reported.

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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Manufacturer Narrative

Event Description

It was reported that on (b)(6) 2008 the patient presented with leg pain and underwent posterolateral intertransverse fusion l4-l5 using lanx pedicle instrumentation and local bone graft as well as infuse performed with no complications.Per medical record "the disc space was so collapsed that the interbody fusion device could not be inserted.The stenosis was very high grade and there was an inflammatory phlegmon stuck to the dura posteriorly.".

Manufacturer Narrative

Review of radiographic images found as follows: (b)(6) 2008 ap and lateral fluoroscopic lumbar x-rays show interoperative lumbar spine with pedicle screws in l4 and l5 bilaterally.Rod spans the screws on the left, but not on the right.Lateral view verifies a grade two isthmic spondylolisthesis with considerable degenerative change with some vacuum disc phenomena seen within the l4 disc.

Event Description

It was reported that on (b)(6) 2005 the patient presented for mri of the lumbar spine due to painful spondylolisthesis.Impression: grade 1 spondylolisthesis of l4 on l5 with severe narrowing of neural foramina, severe degeneration of the l4-5 intervertebral disk.Bony hypertrophy a the pars defects of the lateral recesses is also seen.There is severe degeneration of the l1-2 disk.There is prominent bulge in the disk annulus that is impinging on the distal spinal cord a few centimeters proximal to the conus.There is mild to moderate stenosis from a disk bulge at l5-s1.(b)(6) 2008: the patient presented for a lumbar myelogram and a history of back pain with prior trauma.Impression: the fluoroscopic myelogram demonstrates thecal sac compression, moderate to severe at l1-2 and fairly high grade stenosis at the l4-5 level.There is also a compression fracture at l1 with apparent disk bulge l1-2 disk level.The patient has severe anterolisthesis of 4 and 5 with the resulting disc disease causing a severe compression of the canal.At the level of l4, on the lateral projection, there is significant anterolisthesis of 4 on 5 where the thecal sac is severely compressed anteriorly.There is minimal contrast traveling beyond the obstruction.A defect is also seen at the l1-2 level where an apparent large disc bulge is compressing the thecal sac.Following this study, ct myelographic images were obtained.Impression: there is a low lying thecal sac which terminates at l3.There is anterior compression of l1 with l1-2 severe disc disease.The disc disease is resulting in anterior thecal sac effacement.Cerebrospinal fluid is still seen within the thecal sac outline the nerve roots.Mild foraminal stenosis at the l1-2 levels is seen.Severe disc disease at l4-5 with a grade 2 anterolisthesis is also seen that causes an abrupt kink of the thecal sac.Although, there is cerebrospinal fluid seen within the thecal sac.The neural foramina at this level, is nearly completely effaced.(b)(6) 2008: the patient presented with low back pain.Epidural steroids are no longer effective.The pain occasionally radiates to her coccyx.The patient reports diarrhea and occasional urinary retention.The patient complains of weakness in her anterior thighs bilaterally.Examination found tenderness along the lumbar spine.There is tenderness at the sciatic notch on the right.Radiographs of the lumbar spine show grade 2 spondylolisthesis is present at l4-5.Ct myelogram demonstrates complete myelographic block at l4-5.(b)(6) 2008: the patient presented with a preoperative diagnosis of spondylolisthesis with stenosis l4-5.The patient underwent a pos terolateral intertransverse fusion, l4-5 using pedicular instrumentation and local bone graft as well as rhbmp-2/acs.Per the op notes, the disc space was so collapsed that an interbody fusion device could not be inserted.The stenosis was very high grade and there was an inflammatory phlegmon stuck to the dura posteriorly.Bone graft was packed along the intertransverse membrane between the transverse processes bilaterally.This was supplemented with rhbmp-2/acs bilaterally.No patient complications were reported.(b)(6) 2008: the patient called in with complaints of headaches and loss of appetite when taking lortab.Patient also reports leg cramps at night.(b)(6) 2008: the patient called in with complaints of leg cramps that wake her up.(b)(6) 2008: the patient presented with an incident of severe back pain associated with some increased low back pain and sciatica when she pulled herself up after lying on the floor.It was severe enough that she went to the er.She was given muscle relaxers and pain medication.She continues to report some minimal low back pain and occasional thigh and leg pain on the right.She is wearing her corset.Her incision is clean, dry and healing nicely.There is tenderness in the muscles of the low back and there is tenderness in the buttocks.Ap and lateral x-ray s of the lumbar spine show unchanged alignment and continued good position of the hardware.(b)(6) 2008: the patient presented to physical therapy with complaints of pain and stiffness in her back.Exam found tenderness was palpated in the lower lumbar area.The incision was clean, dry and well healed.The patient demonstrates very limited trunk mobility and weakness in the pelvic and lumbar areas.(b)(6) 2008: the patient was discharged from physical therapy where she was found to have functional trunk rom and her stability has improved significantly.(b)(6) 2008: the patient presented with complaints of cramping in her low back.She also complains of occasional lower extremity pain when she over does her activity.Her incision is well healed and nontender.There is still some mild tenderness in her buttocks bilaterally.Lateral x-ray of the lumbar spine shows continued good alignment and position of the implants without lucencies or signs of migration.(b)(6) 2008: the patient presented with occasional back pain but really is generally functional with no limitations.Radiographs of the lumbar spine in a lateral, show good position of the implants.(b)(6) 2009: the patient presented with some low back pain when she over does her activities.Incision is well healed and there is still some mild tenderness along the incision.Flexion extension x-rays of the lumbar spine show good alignment and position of the implants without any motion at the affected segments.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• 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: 3604669
• MDR Text Key: 4071040
• Report Number: 1030489-2014-00367
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• 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,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110709AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2008
• 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): Other
• Patient Weight: 57