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

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

Patient Problems Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via a patient call that post-op on an an unknwon date the patient had progressive pain in left leg, (nerve root) in left leg and it is severe.Also the patient had abnormal sensation in left sacral l area, wasting of gluteus maximus muscle l5 ¿ s1 level, there is bone growth that has grown into neuro-foramen of l5 on the left side.Bone has also grown central spinal canal at left epidural margin where it is compressing s1 nerve root.Severe back pain and loss sexual functions were reported by the patient.Patient lost normal bowel function and had to have surgery.The patient had total of three surgeries on the following dates: (b)(6) 2009, (b)(6) 2012 (date approx.) and (b)(6) 2007.Patient had mri on (b)(6) 2018,details have not been provided.On (b)(6) 2009: the patient underwent alif (anterior lumbar interbody fusion) where globus cage was implanted with rhbmp-2/acs.On (b)(6) 2012 (date approx.): the patient underwent an unspecified surgery where rhbmp-2/acs was used.On (b)(6) 2017: the patient was again implanted with rhbmp-2/acs.The patient lost sexual function after her 1st surgery and has intestinal and neurological issues involved.At 8 weeks she had a miscarriage ¿ (b)(6) 2017 (9 months.After 2017 surgery).Latest mri showed bone growth at the l5 nerve root and into the canal affecting s1.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Patient complained that on an unknown date, post-op, "rhbmp-2/acs grew into her s1 nerve canal and unfortunately she lost her left gluteus maximus, have terrible radiculopathy worse on the left, and the patient was no longer able to work.Patient also lost autonomic nerve function into some of her pelvic organ and her ¿gi¿ tract for which she is now being worked up for a stoma." (b)(6) 2009: the patient was presented with the following pre-op diagnosis: degenerative disc disease, l4-l5.She underwent following procedures: alif, l4-l5, coalition cage, 8 degrees of lordosis, 13 mm cage.Bmp for bone graft substitute, small kit.Anterior fixation screws with plate.As per operative notes, ¿the l4-l5 disc space was identified and incised.There was very little nuclear material left within the disc space.All fibrous tissue from within the disc space was removed back to the posterior longitudinal ligament.Various trials were placed.The trial that fit the best was a #13 trial with 8 degree of lordosis.At this time the real device was then opened up on the back table.Bone morphogenetic protein had been soaking for approx.60 minutes.Two bmp soaked collagen sponges were placed into the center chamber.The device was then implanted into the disc space.Then 30 mm screws were placed, 1 up and 2 down through the plate, through the device.¿ 10 feb 2011: the patient was presented with the following pre-op diagnosis: pseudarthrosis, l4-5.Status post anterior lumbar interbody fusion, l4-5, with globus implant and bmp2.Status post anterior revision right l5 screw.Lumbar radiculitis.(b)(6) 2012: the patient underwent following procedures: revision posterolateral fusion l4/5 with bmp.Left l5/s1 tlif.As per op notes, ¿¿on the left side of pedicle screws were threaded through the old pedicle screws holes.6x35mm into l4, 6x30mm on l5 and 6x40mm into s1, the latter with bicortical purchase.Bmp placed only to the left l4/5 posterolateral gutter after decortication of the bony areas¿¿ (b)(6) 2017: the patient was presented with the following pre-op diagnosis: spondylosis with radiculopathy, lumbar region.Spinal stenosis, lumbar region.Spondylolisthesis, lumbar region.Prior fusion l4-s1 at outside institution.She underwent following procedures: laminectomy l3-l4.Transforaminal lumbar interbody fusion(tlif) l3-l4.Osteotomy l3/4 dorsal column.Fluoro-c arm.Stealth.Pedicle screw monitoring-psm.Bmp.As per operative notes, ¿i beveled the end plates and resected the entire disk.I placed two cages 11 and 9 mm in height.I then gently compressed the posterior rods and found that we were unable to achieve any significant lordosis.I removed the rods, removed the back cage and again compressed.At this point i went ahead and removed the cage which was 11 mm in height and replaced it for a 9 mm height cage.I was seeking to see if less tension across the annulus would allow for improved lordosis.At this point the osteotomy had been completed.The bone graft which was placed in and around the cages included local bone graft, cancellous allograft, extra small bmp, and 12 cc of bone marrow aspirate harvested from the left ilium.".

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7471724
• MDR Text Key: 106834368
• Report Number: 1030489-2018-00619
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 01/20/2019
• Supplement Dates FDA Received: 02/18/2019
• 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; Required Intervention
• Patient Age: 46 YR