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

Catalog Number 7510200

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

Patient Problems Neuropathy (1983); Swelling (2091); Tingling (2171); Joint Swelling (2356); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on: (b)(6) 2007: the patient underwent mri of the lumbar spine which showed all of the discs to appear normal, except for l4-5 and l5-s1.(b)(6) 2007: the patient underwent emg nerve conduction studies which showed abnormality of the left anterior tibialis muscle, consistent with left l5 radiculopathy.(b)(6) 2007: the patient underwent pre-op x-rays of the chest.Impression: no definitive acute cardiopulmonary disease.(b)(6) 2007: the patient was admitted with the following diagnosis: displacement of lumbar intervertebral disc, l4-5, l5-s1.Lumbar radiculopathy.Low back pain.Mri of the lumbar spine was reviewed which revealed disc pathology at l4-5 and l5-s1; evidence of lumbar radiculopathy due to disc displacement at l4-5 and l5-s1.He underwent the following procedures: arthrodesis, anterior interbody technique, lumbar, l5-s1.Arthrodesis, anterior interbody technique, lumbar, l4-5, additional level.Application of prosthetic device into vertebral defect/interspace, l4-5.Application of prosthetic device into vertebral defect/interspace, peek lt implant, with rh-bmp2/acs, additional level.Vertebral corpectomy, partial, anterior approach, decompression of cauda equina and/or nerve root, lumbar, l4-5.Vertebral carpectomy, partial, anterior approach, decompression of cauda equina and/or nerve root, lumbar, additional level l5-s1.Anterior instrumentation, three vertebral segments, plate.Microscopic magnification and illumination for microsurgical dissection of the posterior longitudinal ligament from the underlying dura, while performing the partial carpectomy.Other implant used: hyrosorb shield.Per op notes, a double barrel 16 mm tang was inserted at l4-5.Bilateral decompression was secured using the reamers set at 23 mm.Bilateral 16 mm x 23 mm peek implants were threaded and then countersunk to the 6 mm mark.The tang was then removed.A double barrel 14 mm tang was inserted at l5-s1.Both barrels were reamed.The debris was removed.Bilateral 14 mm x 21 mm peek lt implants were threaded and countersunk to the 6 mm mark.Approximately 1 hour prior to this point of the procedure, the rh-bmp2/acs was reconstituted and the collagen sponges were soaked with the rh-bmp2/acs.The rolled sponges were then inserted.There were 2 sponges per 16 mm implant at l4-5.There was a single sponge per 14 mm implant at l5-s1.A 23 mm plate was used at l4-5 and a 21 mm plate was used at l5-s1.A total of three 25 mm screws were used at l4-5.Two 20 mm screws were used in the s1 vertebral body and a single 25 mm screw was used at the l5 vertebral body.The plates were offset.At l5-s1, the plate was offset to the right of the midline.At l4-5, the plate was offset to the left of the midline.At l4-5, the plate was set so that there was a single screw in the 15 vertebral body and 2 screws in the s1 vertebral body.At l4-5, the plate was turned so that there was a single screw in the l5 vertebral body and 2 screws in the l4 vertebral body.All screws were tightened.The locking caps were then placed at l4-5 and l5-s1.An intraoperative x-ray was taken that showed the screws and plates, along with implants were in good position at l4-5, l5-s1.No patient complications were reported.(b)(6) 2007: the patient presented for an office visit.(b)(6) 2007: the patient was discharged with the following diagnosis: displacement of lumbar intervertebral disc, l4-5, l5-s1.Lumbar radiculopathy.Low back pain.(b)(6) 2007: the patient presented with intractable low back pain, sharp pain in right anterolateral thigh and left ankle swelling.He also complained of pain at the incisional site.He underwent x-rays of lumbar spine to check fusion.Impression: anterior spinal fusion of l4-5 and l5-s1 with intervertebral disc spacer devices at the l4-5 and l5-s1; near anatomic alignment.(b)(6) 2007: the patient presented for an office visit with mild pain.He also complained of numbness in the right lateral thigh in the distribution of the lateral femoral cutaneous nerve.He underwent x-rays of the lumbar spine.Impression: status post l4-5 and l5-s1 fusion.(b)(6) 2008: the patient presented for an office visit and complained of lower back locking up while sleeping.His gait was slightly antalgic with the use of a cane.The patient underwent x-rays of lumbar spine to check fusion.Impression: status post discectomy and fusion at l4-5 and l5-s1.(b)(6) 2008: the patient presented with low back pain.He also had cold and cough which caused him more pain.The patient also complained of numbness and tingling into the right anterolateral thigh.He also reported difficulty in sleeping due to pain.He underwent x-ray of lumbar spine for checking fusion.Impression: status post discectomy and fusion at l4-5 and l5-s1.(b)(6) 2008: the patient presented with back pain.The pain was worse in his right lower back and down the leg, but it was definitely bilateral.The pain was described as aching, shooting, numbing and intense.Psychiatric examination revealed depression and anxiety.(b)(6) 2008: the patient presented for an office visit with increased back pain.He underwent x-ray of lumbar spine.Impression: status post l4-5 and l5 anterior fusion, unchanged.(b)(6) 2008: the patient underwent ct of lumbar spine, which revealed good bone consolidation and fusion between l4-5 and l5-s1; plates and screws are with good alignment and fixation; l3-4 disc bulge.(b)(6) 2008: the patient presented with some mild decreased sensation in the right anterior portion of the thigh.(b)(6) 2014: the patient underwent mri of lumbar spine due to lumbar radiculopathy.Impression: post-surgical changes.Numbering configuration assumes postsurgical changes are at l4, l5 and s1.Mild central disc bulging at l5-s1.Question very small central disc herniation.No spinal stenosis or mass effect.Minimal disc bulging l4-l5.No disc herniation or spinal stenosis.Mild to moderate facet changes.

• 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: 5044127
• MDR Text Key: 24658761
• Report Number: 1030489-2015-02129
• 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: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110701AAF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2007
• 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: 100