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

Model Number 7510800

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

Patient Problems High Blood Pressure/ Hypertension (1908); Seizures (2063); Chronic Obstructive Pulmonary Disease (COPD) (2237); Anxiety (2328); Injury (2348); Depression (2361)

Event Date 02/12/2014

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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) 2014: patient discharged with following diagnosis: mechanical complications of orthopedic device, unclassified.Assessment: s/p re-instrumentation l1-s1 and fusion.

Manufacturer Narrative

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) 2016 patient presented for an office visit due to upper back surgery.Assessment: unspecified adrenocortical insufficiency; back pain; pre-op examination.On an unknown date patient underwent chest (pa+ lateral) pre-op exam specified other.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2015 the patient underwent x rays of the shoulder.Impression: calcific tendinosis of the rotator cuff.Moderate degenerative changes of the acromioclavicular joint.On (b)(6) 2015 per billing records, the patient underwent ct scan of head.Impression: no hemorrhage, midline shift od other significant mass effect.On (b)(6) 2015: patient presented with complaint of increase in back pain due to fall in a bathtub.Patient continues pain management.Patient underwent x-ray which revealed her instrumentation was intact.Patient was in slightly positive sagittal balance secondary to pjk.On (b)(6) 2016: patient underwent mri of cervical spine wo contrast.Impression: at the c3-4, c4-5 and c6-7 levels, there has been interval development of small central posterior disc herniation/ protrusions which mildly efface the thecal sac.At the c5-6 level, stable small posterior disc bulge mildly effaces the thecal sac.No spondylolisthesis.Interval development of mild degenerative wedding of the t3 vertebral body.Post-operative changes in the remainder of the visualized upper thoracic spine.On (b)(6) 2016: patient presented for a follow up visit with complaint of upper back pain.Mri of cervical spine did not show any significant spinal canal stenosis.On (b)(6) 2016 the patient underwent x ray of the entire spine.Impression: extensive thoracic lumbosacral hardware is present.No hardware failure is identified.Disc space surgery has been performed at l2-3, l3-4, l4-5, l5-s1.Postoperative or post-traumatic bony deformity is seen at l3.On (b)(6) 2016, patient underwent following procedure: partial removal of segmental spinal instrumentation; exploration of fusion; t3 pedicle subtraction osteotomy; t1 to t9 segmental spinal instrumentation; t1 to t9 bilateral posterolateral fusion; local autogenous bone for fusion; application and removal of gardner-wells tongs.Pre-op and post-op diagnosis: stenosis; t3 fracture; t3 to pelvis segmental spinal instrumentation.On (b)(6) 2016 the patient underwent x rays of the lumbar spine.Impression: multiple postoperative changes as described above without complication on x ray.Mild/moderate degenerative change.Slight loss of lumbar lordosis exaggerated cervicothoracic kyophosis.Slight loss of cervical lordosis.Minor multilevel anterolisthesis.Minor residual scoliosis.On (b)(6) 2016: the patient presented for an office visit for follow-up, with complaint of back pain and for medication refill.On (b)(6) 2016: the patient presented for follow-up.Assessment: hypothyroidism.Htn (hypertension).Copd (chronic obstructive pulmonary disease).Depression with anxiety.Seizure disorder.Other abnormal glucose.Back pain.On (b)(6) 2016: patient presented for a follow up visit post fusion due to fracture of rods.Patient continues to experience pain.On (b)(6) 2016: the patient presented for an office visit with chief complaints of cough, up dark green phlegm, head <(>&<)> sinus congestion, chest congestion, problems with eyes.The patient fell in grass in front of house, had bruise on left leg.The patient also had an attack from addison's disease few days ago.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5472577
• MDR Text Key: 39422689
• Report Number: 1030489-2016-00582
• 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: 09/20/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 7510800
• Device Catalogue Number: 7510800
• Device Lot Number: M111401AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/05/2016; 10/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2014
• 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: 00052 YR
• Patient Weight: 68