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 Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Stenosis (2263); Anxiety (2328); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544)

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.Multiple products 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

It was reported that on (b)(6) 2007 patient presented with preoperative diagnosis of hardware failure with migration of inter body device and underwent removal of inter body device, insertion of new inter body device, pedicle screw insertion, left l5, evaluation of fusion mass, posterolateral fusion, l4-s1 bilaterally, revision hardware bilaterally.Procedure description: set screw was removed from l4 and s1 and subsequently the rod was removed as well.Dissection was carried down to the inter body device at l4-5.Interbody device was removed without any complications.There was no evidence of inter body fusion or mass.Bmp and astrograft were placed into the posterolateral gutters on the left without complications.Dissection was carried out laterally with transverse processes and the sponge and astrograft were plated out laterally.Inter body device was then placed at the l4-5 level.Prior to this, bmp sponge and astrograft were placed anteriorly and within the inter body device fluoroscopy was used and visualized during insertion of the device to ensure good placement.On (b)(6) 2008: patient presented which chief complaint of neck pain with radiation of pain close to his left shoulder, left arm, tingling and numbness in his left hand.Patient also complains of lower back pain with radiation down close to his left lower extremity.Patient was diagnosed with degenerative disk disease.Patient also complains of pain in his left leg.Physical examination: range of motion is restricted.Evaluation of lumbar spine there are scars of previous surgeries with nice healing.Forward flexion and backward extension of lumbar spine is limited and painful.X-ray examination of lumbar spine shows the position of instrumentation is intact.Suspicious to halo around l4 screw, suspicious to non union in patient.Impression: non union of l4-s1, degenerative disc of cervical spine.It was reported that there is a non union of l4-s1.On (b)(6) 2008: the patient underwent mri of cervical spine.Impressions: there is some degenerative disc disease at the c2-3, c4-5 and c5-6 levels as discussed above.There is borderline spinal stenosis t the c4-5 c5-6 levels.There was no evidence of a herniated disc.On (b)(6) 2008: patient underwent ct scan of lumbar spine due to low back pain.Findings: spiral scanning from t12 through the upper sacrum was performed with multiplanar reconstructed images generated, including 3d reformatted images.Normal alignment is maintained.There is no evidence of acute fracture or vertebral body subluxation.No abnormality is seen at t12-l1, l1-2 or at l2-3.The lumbar canal is small with congenitally short pedicles demonstrated at l3, l4 and l5.At l3-4, there is evidence of mild disc bulge without herniation.The patient has undergone posterior and interbody fusion from l4 through s1.Posteriorly connected are bilateral pedicle screws at l4, l5, and s1.The l4 and l5 pedicle screws are near the superior endplate of the vertebral bodies.No hardware fracture is seen.At l4-5, interbody graft material has been placed within the intervertebral discs from a left posterior approach.This appears to be incorporate with contiguous endplates.There is heterogeneous irregular-shaped ossification along the left posterior track of the graft material.There is mild facet arthropathy on the right.There is fusion of the left l4-5 facet joint.This creates marked stenosis of the left l4-5 neural foramen, as well as mild mass effect upon the left side of the spinal canal.There is mild narrowing of the right l4-5 neural foramen.On (b)(6) 2008: patient presented for evaluation.Cervical spine mri is compatible with disc degeneration, disc bulge, hiz at the level of c4-5 with mild foraminal stenosis.Ct of lumbar spine is compatible with some heterotrophic bone formation posteriorly on the left side and suspicion to nonunion.

Event Description

On (b)(6) 2007, the patient underwent posterolateral fusion from vertebrae l4 to s1.The patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the lateral gutters).Allegedly, post-op, "the patient continues to experience chronic lower back pain, with pain radiating to his hips and legs, and numbness and tingling in his legs.He is unable to sit, stand or walk for any extended period.If he attempts any household chores, he is bedridden for one to two days.Patient also suffers from sexual dysfunction and anxiety.".

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6029244
• MDR Text Key: 57417671
• Report Number: 1030489-2016-02892
• 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,Followup,Followup
• Report Date: 01/09/2017

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: 09/20/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided; 01/09/2017
• Supplement Dates FDA Received: 02/02/2017; 09/26/2017
• 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): Required Intervention
• Patient Weight: 118