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

Catalog Number 7510800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Neuropathy (1983)

Event Type  Injury  

Manufacturer Narrative

(b)(4): neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on: (b)(6) 2009: the patient presented with chief complaint of pain and numbness in arms.The patient had scar back mild stenosis.(b)(6) 2009: the patient underwent sra spine thoracolumbar ap <(>&<)> l.Impression: patient is status post laminectomy and fixation at the l4-l5 level with persistent high grade anterolisthesis of l5 on s1 with posterior element fractures.(b)(6) 2010: the patient underwent sra scoliosis complete study.Impression: grade 3 anterolisthesis of l5-s1, stable.The patient underwent sra lumbar spine flex/ext.Impression: grade 3 anterolisthesis of l5 on s1, stable.No significant movement of l5 on s1 is seen on the flexion view.(b)(6) 2011: the patient presented with preoperative diagnosis of spondylolisthesis with nonunion l4-s1 fusion.The patient underwent revision posterior spinal fusion with instrumentation l4 to s1.Decompression s1 to s3.Exploration of spinal fusion.Structural allograft bone graft.Repair of dural leak.Autograft bone graft from same incision.Cancellous allograft bone graft.Insertion of rh-bmp2/acs.Per-op notes: the patient was placed in the supine position and given general anesthetic.The residual allograft sticking out from behind the sacrum was then burred down utilizing the midax rex.There was excellent fixation of the allograft and this was quite rigid.Inspection of the dura revealed a dural leak on the side at the axilla of the s2 nerve root.Surgeon performed a duraplasty but was unable to completely close this.We utilized some muscle and fat as well as fibrin glue to seal this area.The wound was copiously irrigated with antibiotic solution.Allograft cancellous chips were then placed from l4 to s1 and a large rh-bmp2/acs was inserted on each side followed by additional allograft and rh-bmp2/acs.The deep fascia was then closed.Steri strips were applied followed by 4x8s and hypafix.The patient was then turned to supine position and extubated without difficulty.(b)(6) 2011: the patient presented with spondylolisthesis grade 3 and scoliosis.The patient presented with back pain and nausea.The patient underwent physical examination.Neurological: sensation in lower extremities.The patient presented for revision lumbar spinal fusion.(b)(6) 2011: the patient presented for follow up visit.(b)(6) 2011: the patient presented with pain, headache and dizziness.(b)(6) 2011: the patient presented with headache.The patient underwent ct lumbar spine w/o contrast.Impression: new postsurgical changes.New diffuse dorsal parapinal soft tissue non specified fluid is present from the l2 level through the upper sacrum.The fluid could reflect evolving post operative changes.A cerebral spinal fluid leak, abscess, or evolving soft tissue hematoma could be considered in the appropriate clinical setting.(b)(6) 2011: the patient presented with headache, back pain and nausea.(b)(6) 2011: the patient was discharged.(b)(6) 2011: the patient underwent sra lumbar spine ap/ lat.Impression: anterolisthesis of l5 and s1.(b)(6) 2011: the patient underwent sra lumbar spine ap/lat.Impression: stable postsurgical appearance of the lumbar spine.21 jun 2011: the patient underwent sra spine thoracolumbar ap <(>&<)> l.Impression: stable appearance of the lumbar spine.(b)(6) 2011: the patient underwent us renal s <(>&<)> i.Impression: echogenic debris within the urinary bladder with mild bladder wall thickening compatible with history of urinary tract infection.Normal sonographic appearance of the kidneys.(b)(6) 2011: the patient underwent sra lumbar spine ap/lat.Impression: grade 4 spondylolisthesis of l4 on l5, status post fixation of l4 to the sacrum.27 apr 2012: the patient underwent sra lumbar w/obliques.Impression: unchanged advanced anterolisthesis of the l5 vertebral body on s1.(b)(6) 2012: the patient underwent us kidneys and bladder.Impression: normal kidney without evidence of hydronephrosis, incidental 4.5cm simple right ovarian cyst.(b)(6) 2013: the patient underwent sra scoliosis complete study.Impression: unchanged minimal dextroscoliosis of the thoracic spine.(b)(6) 2014: the patient admitted with chief complaint of pst evaluation.(b)(6) 2014: the patient admitted with chief complaint of s/p b/i gluteal advancement flaps.The patient presented with preoperative diagnosis of chronic wound sinus tract of midline buttock.The patient underwent excision of sinus tract as well as bilateral gluteus maximus muscle flaps as well as complex closure, approximately 10.5cm.

• 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: 5203611
• MDR Text Key: 30473010
• Report Number: 1030489-2015-02924
• 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
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M1110504AAF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• 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): Other
• Patient Weight: 74