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

Catalog Number 7510600

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

Patient Problems Incontinence (1928); Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); 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.

Event Description

It was reported that on (b)(6) 2011, the patient underwent anterior lumbar interbody fusion surgery on the lumbar region of her spine from vertebrae l2 to l4 and l5 to s1.Allegedly, patient was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space).Reportedly, "patient's post-operative period was marked by a period of improvement, followed by increasingly severe low back pain, with associated pain and radiculopathy in her left leg." reportedly, "patient continues to experience chronic low back pain, with pain radiating to her left hip, numbness and tingling down her left leg, and left foot drop.She experiences difficulty sitting, standing and walking.Patient also suffers from occasional urinary incontinence.".

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2011, the patient presented with following pre-op diagnosis: degenerative disc disease, l2-l3, l3-l4, l4-l5, and l5-s1; spinal stenosis, l2-l3, l3-l4, l4-l5, l5-s1; recalcitrant back and lower extremity radicular pain.She underwent following procedures: anterior and posterior spinal fusion l2-l3, l3-l4, l4-l5, l5-s1; insertion of interbody fusion device (rhbmp-2 sponges) anterior l2-l3, l3-l4, l4-l5, l5-s1; laminotomy, partial medial facetectomy and foraminotomy for neural decompression, bilateral l2-s1; segmental pedicle instrumentation l2-l3, l3-l4, l4-l5, l5-s1.As per operative notes,¿ the centers of the devices were filled with cortico-cancellous allograft bone.Each device was positioned within a distracted disc space between l2 and s1.Additional cancellous allograft bone and rhbmp-2 sponges were positioned bilaterally adjacent to each device.¿ no intra-operative complications were reported.(b)(6) 2011: the patient underwent post-op evaluation of the lumbar spine.Findings: there are posterior rods and pedicle screws seen at l2 through s1.Pedicle rods are paired at l2, l4 and s1 and the lateral left at l3.An intervertebral graft material is seen at l2-3, l3-4, and l5-s1.An anterior compression plate and mature graft material is seen at l4-5.Anatomic alignment is present.There is laminectomy defect seen at l3, l4 and l5.

• 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: 6025340
• MDR Text Key: 57249541
• Report Number: 1030489-2016-02876
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2013
• Device Catalogue Number: 7510600
• Device Lot Number: M111054AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2011
• 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