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 Dyspnea (1816); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Irritability (2421); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684)

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) 2002, the patient underwent a procedure.Preoperative diagnosis: internal disc herniation, l2-3, central disc herniation, spondylosis.Preop notes: that whole spinous process, bilateral laminae, facet areas were morsellized, were removed, morsellized and used for bone graft.The annular areas were then exposed on both sides.Hemostasis was maintained by bipolar electrocautery.Roots were retracted.Procedure was used with rotating box cutters, curettes, and box cutters were used to open up the disc space to accept a 14 mm cage.Once the endplates were cleaned out, two 14 mm cages were taken.They were packed with 2 sponges that had been soaked with rhbmp-2 and then driven into place.Acceptable distraction was taken.Pedicles were then located by the c-arm, first on the right side, placing 2 pedicle screws there under image ct guidance and then on the left side with image intensifier guidance.A 50 mm demineralized bone matrix strip with osteofil was placed on both sides followed by the morsellized bone taken from the laminae.Precontoured rods were then positioned over the screws and inferior ends were tightened.Compression was carried out and then the set screws were wrung off.Gelfoam soaked in thrombin was placed over the dura.Cages were also in acceptable position by x-rays, being well within the confines of the disc space.It should be noted that one sponge soaked with rhbmp-2 was placed between the 2 cages anteriorly.On (b)(6) 2010, the patient was presented for office visit for med refill and follow up.Assessments: back pain, thoracic spine.On (b)(6) 2010, the patient was presented for office visit with med refill and gastric cramping no change in bowel habits.Assessments: abdominal pain, back pain, thoracic spine, knee pain, trochanteric bursitis.On (b)(6) 2010, the patient underwent mri of the thoracic spine.Impressions: there was subtle paracentral disc protrusion on the right at the t8-t9 level.There was a small amount of t2 signal in this :region suggesting a small annular tear in the midline at this level.This slightly indents the ventral subarachnoid space but does not appear to deform or displace the cord.Remaining visualized levels of the thoracic spine do not show further abnormality.The patient also underwent mri of the lumbar spine.Impressions: no complication was reported.On (b)(6) 2010, (b)(6) 2011, the patient was presented for office visit for 3 months checkup.Assessments: folliculitis, disc, lumbar, back pain, thoracic, hyperlipidemia.On (b)(6) 2011, the patient was presented for office visit with lab results.Assessments: hyperlipidemia, fatigue, unspecific vitamin d deficiency.On (b)(6) 2011, the patient was presented for office visit for health assessments.Assessments: need for influenza vaccine, need for tdap, acute maxillary sinusitis, insomnia, microscopic hematoria, vitamin d efficiency, 7) anxiety.On (b)(6) 2012, the patient underwent ct scan of abdomen.Impressions: there was borderline to mild porta hepatis lymph node enlargement.Small cyst noted in the lower pole of the left kidney.On (b)(6) 2012 ,the patient was presented for office visit with general checkup; sinus started with cough.Assessments: bronchitis, insomnia, lung nodule.On (b)(6) 2012, the patient was presented for office visit for general checkup.Assessments: 10 back pain, disc, lumbar.On (b)(6) 2012, the patient was presented for office visit with pain down right buttock down right leg and had trouble with starting urination.Assessments: dysuria, hyperlipidemia, back pain, thoracic spine, prostatitis, fatigue, benign essential hypertension.On (b)(6) 2012 the patient was presented for office visit with lab results.Assessments: dysuria, hyperlipidemia, back pain, thoracic spine, prostatitis, fatigue, benign essential hypertension.On (b)(6) 2012, the patient was presented for office visit for review of lab results.Assessments: back pain, thoracic spine, fatigue, benign essential hypertension, hyperlipidemia.On (b)(6) 2012 ,the patient was presented for office visit for 3 months checkup and getting a carcinoid removed.Assessments: 1) back pain, thoracic spine on (b)(6) 2013, the patient was presented for office visit for three months checkup.Assessments: back pain, thoracic spine; chronic use of steroids.On (b)(6) 2013, the patient was presented for office visit rechecking back.Patient also reported irritability, fatigue, light headedness, shortness of breath.Assessments: depression; anxiety; low back pain; benign essential hypertension; hyperlipidemia.

• 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: 5181904
• MDR Text Key: 29681360
• Report Number: 1030489-2015-02815
• 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
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Device Lot Number: MA111001B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• 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): Other
• Patient Weight: 77