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 Calcium Deposits/Calcification (1758); Pain (1994); Weakness (2145)

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.

Event Description

It was reported that on (b)(6) 2009, patient presented with preoperative diagnosis: an l1 burst fracture with significant canal compromise and loss of height.Status posts an l1 corpectomy via an anterolateral approach.Left lower extremity weakness and bilateral lower extremity numbness.Procedure: a t11-l2 arthrodesis.T11-l2 posterior instrumentation with bilateral pedicle screws at t11, t12, and l3 with bilateral laminar hooks on the top of l2.Intraoperative interpretation of fluoroscopy of less than minutes.Intraoperative ssep and mep.Per-op notes: the appropriate sized rod bent with a thoracic curve was then used to connect the t11-l3 pedicle screws bilaterally.Each screw cap was then placed and torqued to the appropriate length.Some compression was done between the laminar hook, as well as the l3 pedicle screw to term a claw construct caudally.The area was then copiously irrigated using a high-speed drill, the spinous processes and lamina were decorticated room l3 up to t11.Cancellous allograft bone chips were then wrapped in bmp and spanned room t11-l3 tor posterolateral fusion.Additional bone chips were also packed on top of the cancellous bone chips and bmp rolls.Two cross links were placed, 1 in the middle of the construct, as well as at the rostral end of the construct.All of the screw caps were torqued to the appropriate pressure, as well as the caps of the cross links.The retractors were then removed.The muscle and fascia were then closed with interrupted 0 vicryl sutures.The subcutaneous tissue was then closed and reapproximated with interrupted 2-0 vicryl sutures.The skin was then closed and reapproximated with a running 2-0 nylon.The incision was cleaned and dried, sterile dressings were placed on top.There was no patient complication.On (b)(6) 2009, patient presented with coughing problem.Findings: no pneumothorax is identified; however, a supine film is suboptimal for that determination.An erect film of the chest is suggested in order to more accurately exclude a pneumothorax.The right lung and left lung are clear.On (b)(6) 2009, patient discharged.On (b)(6) 2009, patient underwent radiology test.Impression: no bony abnormality of the left hip.On (b)(6) 2009, patient underwent l1 burst fx test.Impressions: satisfactory alignment of the lumbar spine alignment subsequent to hemicorporectomy of l1 and spine stabilization both posterior as well as lateral.On (b)(6) 2009, patient underwent ct brain without contrast.Impression: negative.Ct abdomen and pelvis impression: non obstructive bilateral nephrolithiasis.Patient is status post t11-t3 a pinal fixation.On (b)(6) 2009, patient presented for follow-up visit.Ct thoracic and lumbar spine performed.Impression: stable posterior stabilization from t11 to l3 without evidence of hardware failure or infection.The thoracolumbar spine remains in satisfactory alignment.No significant change in anterior wedge compression deformity of t12.On (b)(6) 2010.Patient presented with chronic pain.X-ray of the i-spine having impression: postoperative changes are present involving the lower thoracic and upper lumbar spine with a mild compression deformity of t12 and possibly minimal retropulsion of l 1.Multiple calcifications overlie the right kidney." her emg is does not show peripheral nerve injury."normal study." no edx evidence neuropathy or lumbar radiculopathy of the area tested in the left lower extremity at this time.Impression: left leg weakness and loss of mass after spinal fractures, and likely incomplete spinal cord injury at the cauda equina or conus level-no bowel bladder; pain and spasms; she still has list of other pain providers but states she wants to continue here for pain care.On (b)(6) 2010, patient presented with problem of musculoskeletal.X-ray of the i-spine having impression: postoperative changes are present involving the lower thoracic and upper lumbar spine with a mild compression deformity of t12 and possibly minimal retropulsion of l 1.Multiple calcifications overlie the right kidney." her emg is does not show peripheral nerve injury."normal study." no edx evidence neuropathy or lumbar radiculopathy of the area tested in the left lower extremity at this time.Impression: left leg weakness and loss of mass after spinal fractures, and likely incomplete spinal cord injury at the cauda equina or conus level-no bowel bladder; pain and spasms; she still has list of other pain providers but states she wants to continue here for pain care.On (b)(6) 2010, patient presented with chronic pain.X-ray of the i-spine having impression: postoperative changes are present involving the lower thoracic and upper lumbar spine with a mild compression deformity of t12 and possibly minimal retropulsion of l 1.Multiple calcifications overlie the right kidney." her emg is does not show peripheral nerve injury."normal study." no edx evidence neuropathy or lumbar radiculopathy of the area tested in the left lower extremity at this time.Impression: left leg weakness and loss of mass after spinal fractures, and likely incomplete spinal cord injury at the cauda equina or conus level-no bowel bladder; pain and spasms; she still has list of other pain providers but states she wants to continue here for pain care.On (b)(6) 2011, patient presented with chronic pain.X-ray of the i-spine having impression: postoperative changes are present involving the lower thoracic and upper lumbar spine with a mild compression deformity of t12 and possibly minimal retropulsion of l 1.Multiple calcifications overlie the right kidney." her emg is does not show peripheral nerve injury."normal study." no edx evidence neuropathy or lumbar radiculopathy of the area tested in the left lower extremity at this time.Impression: left leg weakness and loss of mass after spinal fractures, and likely incomplete spinal cord injury at the cauda equina or conus level-no bowel bladder; pain and spasms; she still has list of other pain providers but states she wants to continue here for pain care.Lumbar spine radiographs impression: postoperative changes of the lower thoracic and upper lumbar spine with posterior and lateral fixation hardware as described above.No specific radiographic evidence of hardware loosening.Degenerative changes of the lower lumbar spine.On (b)(6) 2012, patient presented with chronic pain.X-ray of the i-spine having impression: postoperative changes are present involving the lower thoracic and upper lumbar spine with a mild compression deformity of t12 and possibly minimal retropulsion of l 1.Multiple calcifications overlie the right kidney." her emg is does not show peripheral nerve injury."normal study." no edx evidence neuropathy or lumbar radiculopathy of the area tested in the left lower extremity at this time.Impression: left leg weakness and loss of mass after spinal fractures, and likely incomplete spinal cord injury at the cauda equina or conus level-no bowel bladder; pain and spasms; she still has list of other pain providers but states she wants to continue here for pain care.On (b)(6) 2013, patient underwent soft tissue ultrasound.Impression: left suprapubic subcutaneous area of concern corresponds to a complex area with 2 cystic components may correspond to an inflammatory epidermoid, inclusion or sebaceous cyst or reaction to foreign body.

• 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: 5073719
• MDR Text Key: 25626067
• Report Number: 1030489-2015-02332
• 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: 08/17/2015

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: 05/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110711AAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2015
• Initial Date FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2008
• 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: 62