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

Catalog Number 7510400

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

Patient Problems Incontinence (1928); Pain (1994); Weakness (2145); Tingling (2171)

Event Type  Injury  

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.

Event Description

Patient demographics: (b)(6).It was reported that on (b)(6) 2006 the patient presented with weakness of muscles/joints, muscle pain/cramps and severe back pain.Mri indicated degenerative disc disease at l5-s1.The patient was admitted and underwent anterior lumbar interbody fusion, l5-s1 and posterior instrumentation, l5-s1, intrabody cage insert, c-arm fluoroscopic imaging.The bmp and sponges which had been prepared previously were placed into the cages at l5-s1 bilaterally.They were also placed in the lateral portions of the disk space.The patient underwent the following examination: portable lateral lumbar spine 550 and 1605.Impression: on the initial a bone plug was noted at l5-s1 and a metallic localizing needle projects towards the region of the s1-2 disc space; on the second film, a larger metallic probe projects towards the midportion of the body of s1 with a vertically oriented metallic density projecting from the level of the disc space at l5-s1 to the lower border of s1.On (b)(6) 2006, the patient underwent the following abd 2-3 v ap decub <(>&<)>/or erect exam.Impression: a dynamic ileus and postoperative spine.On (b)(6) 2006, the patient underwent the following exam, spine lumbar 2 or 3 views.Findings: surgical bone plug projects between the anterior two thirds of the bodies of l5 and s1 and a long cylindrical shaped metallic density projects over the spinous processes of l5, s1, and the upper border of s2; alignment is normal.On (b)(6) 2006, the patient was discharged.On (b)(6) 2007, the patient underwent computed tomography, lumbar spine without contrast for chronic low back pain.Impression: postsurgical changes.Mild bilateral neuroforaminal stenosis at l5-s1 from degenerative disease.Possible mild central spinal stenosis at l5-s1.On (b)(6) 2007, the patient underwent computed tomography, lumbar spine without contrast and myelography.Impression: at l5-s1, post-surgical changes with interbody cage and interspinous device.No evidence of central foraminal stenosis.There is mild to moderate bilateral foraminal stenosis of questionable clinical significance.Minor degenerative change at other lumbar levels with no evidence of significant stenosis or nerve root impingement.On (b)(6) 2009, the patient underwent an mri scan.It indicated prior fusion with no alteration at l5-s1 levels.No new pathology was found.Mild, multilevel disc and facet joint degeneration was observed.On (b)(6) 2009, the patient presented with back pain and numbness on bilateral legs.On (b)(6) 2009, (b)(4) 2010, the patient presented with back pain, bladder incontinence, tingling in feet and weakness in legs.On (b)(6) 2010, the patient underwent an mri scan.The scan indicated no significant interval change.The l5-s1 fusion was noted and multi minor degenerative changes were observed.No nerve root impingement or significant stenosis was found.On (b)(6) 2012, the patient presented with back pain.

• 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: 5028737
• MDR Text Key: 23986551
• Report Number: 1030489-2015-02084
• 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: 07/27/2015

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: 05/30/2008
• Device Catalogue Number: 7510400
• Device Lot Number: M115009AAB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• 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: 91