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 Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Weakness (2145); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2008 the patient was pre-operatively diagnosed with 1.Lumbar spondylosis.2.Lumbar spinal stenosis.3.Neurogenic claudication and underwent the following procedures: 1.Posterior spinal fusion from l3 to s1.2.Posterior segmental spinal instrumentation from l3 to s1 utilizing the 5.5 mm stainless steel system.3.Laminectomy, bilateral partial medial facetectomies, and bilateral foraminotomies from l3 to ls.4.Augmentation of posterior spinal fusion with morselized local bone graft (40 ml).5.Augmentation of posterior spinal fusion with demineralized bone matrix (10 ml putty).6.Augmentation of posterior spinal fusion with rhbmp-2 (48 mg of rhbmp-2 on 20 ml graft matrix with 2.4 mg/ml graft volume concentration).7.Application of gardner-wells tongs for temporary intraoperative tr action.8.Spinal cord monitoring consisting of somatosensory evoked potentials and electromyography.As per the op notes: ¿at this point, we turned our attention to decorticating the spine.We paid particular attention to decorticating the facet joints bilaterally.We also decorticated the remaining posterior elements including all transverse processes and the sacral ala.Once the spine was thoroughly decorticated, we placed 48 mg of rhbmp-2 on 20 ml graft matrix 2.4 mg/ml graft volume concentration into decorticated facet joints and over the decorticated posterior elements.This was then followed by 40 ml morselized local bone graft mixed with 10 ml putty.¿ post-op, patient reportedly had "progressively worsening and extreme lower back pain and stiffness, radiating pain into his buttocks and down his legs, severe right hip pain, and constant numbness/tingling in his right hip and legs"."severe pain and symptoms ultimately compelled patient to undergo a revision surgery on (b)(6) 2016.Despite revision surgery, patient continues to experience low back pain and occasional muscle spasms, stiffness in his upper back, numbness in his upper right hip and left leg, and weakness in his right leg.He experiences difficulty sitting, standing and walking, and wears a back brace daily.".

• 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 road; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea road; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6897723
• MDR Text Key: 87514197
• Report Number: 1030489-2017-02123
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843812
• UDI-Public: 00681490843812
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110610AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2007
• 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 Age: 62 YR