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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fever (1858); Pain (1994); Fibrosis (3167)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) 2007: the patient presented with severe pain in her back.The patient underwent the following procedures: 1.Removal of instrumentation of lumbar spine.2.Exploration of fusion mass.3.Supplementation of fusion mass/fusion l2 to l5 with rh-bmp2/acs.Per op note, this was done in standard fashion by using rh-bmp2/acs on a collagen sponge wrapping it around the graft matrix and after decorticating the fusion mass applying the composite graft from l2 to l5 in the fusion mass area.No patient complications were reported.(b)(6) 2007: the patient underwent portable chest due to post-op fever and shortness of breath.Impression: fibrotic stranding in both lungs, stable.(b)(6) 2015: the patient presented for a follow up office visit.Ap, flexion/extension lateral x-rays of the lumbar spine demonstrates what appears to be a solid fusion.No obvious loosening of her construct seen, no obvious motion on flexion/extension views.She has stable mild degenerative changes at 5-1.(b)(6) 2007: the patient presented for a follow up office visit.(b)(6) 2007: the patient presented for a follow up office visit.Ap, flexion-extension lateral x-rays of the lumbar spine me reviewed.There is no evidence to suggest any sort of instability or movement.X-ray of her pelvis are unremarkable.(b)(6) 2007: the patient underwent nm bone scan due to complications related to internal orthopedic device.Conclusion: total body bone scintigraphy demonstrates increased tracer uptake within the axial and appendicular skeleton as noted above.(b)(6) 2007: the patient underwent open mri lumbar spine w <(>&<)> w/o contrast due to back pain.Conclusion: mr imaging of the lumbar spine demonstrates extensive postoperative changes.There is no evidence of recurrent herniated nucleus pulposus.There is epidural fibrosis (scarring).(b)(6) 2007: the patient presented for a follow up office visit.Her mri is reviewed she has some epidural fibrosis noted at the 2-3 mid 4-5 levels.Otherwise i don't see any significant pathology, her bone scan is unremarkable.It shows some increased uptake in the areas of her previous surgery.(b)(6) 2007: the patient presented for a follow up office visit.(b)(6) 2007: the patient underwent open mri of lumbar spine with and without contrast due to lumbago.Impression: extensive post-surgical changes identified with transpedicular screws at multiple levels, as above.Disc space narrowing is most prominent at l2-3 and l4-5.No significant interval change is convincingly demonstrated when compared to the prior mri examination from late (b)(6) 2007.Continued clinical correlation with regard to current clinical presentation is recommended.(b)(6) 2007: the patient presented for a follow up office visit.The mri impression shows extensive postsurgical changes identified with transpedicular screws at multiple levels.Disc space narrowing is most prominent at l2-3 and l4-) no significant interval change was convincingly demonstrated when compared to the prim mri examination from late (b)(6) 2007.

• 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: 5064127
• MDR Text Key: 25272115
• Report Number: 1030489-2015-02258
• 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
• Report Date: 08/11/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110606AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2007
• 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: 80