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 Unspecified Infection (1930); Urinary Tract Infection (2120); Weakness (2145); Stenosis (2263); Numbness (2415); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (disc herniation), (b)(4) (revision surgery).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 the device contributed to the reported event, we are filing this mdr for notification purposes.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: on (b)(6) 2005: the patient was pre-operatively diagnosed with lumbar instability, spondylolisthesis, herniated disk, spinal stenosis and underwent posterior non segmental instrumentation, l4-l5, posterolateral fusion l4-l5.Bone morphogenic protein hydroxyapatite.As per op-notes, ¿following decompression, bone morphogenic protein was mixed with hydroxyapatite and placed in the posterolateral gutters bilaterally.Two 5.5 rods were then cut and contoured and appropriate amount of lordosis, scoliosis, put in place, tightened, torqued to 12 ft-lb pressure.The break off screws were broken off.A single 306 crosslink was put into place, tightened and torqued to 12 ft-lb of pressure.Hemovac drain was pulled from the wound.The wound was then closed.¿ no patient complications were reported.On (b)(6) 2005: patient was pre-operatively diagnosed with degenerative disk disease with lateral recess stenosis and underwent bilateral foraminotomy l4-l5 followed by lumbar fusion.On (b)(6) 2005: the patient was pre-operatively diagnosed with: lumbar spinal stenosis and herniated nucleus pulposus at l4-l5: status post, recent posterior lumbar fusion with foraminotomies, decompression at l4-l5; postoperative bowel/bladder dysfunction; bilateral leg weakness and numbness postoperatively; history of degenerative spine disease, cervical and lumbar spine, status post intracervical discectomy and fusion at c4-c5 and c5-c6 for cervical stenosis on (b)(6) 2005; preoperative urine uti, positive staph epidermis; superficial wound infection noted, wound culture positive for coagulase-negative staphylococcus and underwent following procedures: decompressive lumbar laminectomy of l4 and l5, and partially of l3, with lumbar micro discectomy at l4-5, along with removal of cross link lumbar hardware by dr.(b)(6), along with reinsertion; picc line, (b)(6) 2005.

Manufacturer Narrative

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

• 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: 6295690
• MDR Text Key: 66317068
• Report Number: 1030489-2017-00187
• 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
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• 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
• Date Manufacturer Received: 01/09/2017
• 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 Age: 47 YR
• Patient Weight: 79