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

Catalog Number 7510200

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

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Sleep Dysfunction (2517)

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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on per medical records (b)(6) /2009: the patient presented for a pre-op exam.Diagnosis: asthma, irregular and excessive mensuration, dysplasia of cervix nos, thyroid nodule adenomatous, nontoxic, flushing, insomnia, diabetes mellitus subclinical, sciatica, benign neoplasm skin nec, 1 eye-sev/oth-blind nos.Back pain with radiation into left leg.(b)(6) 2009: the patient presented with pre-op diagnosis: 1.Degenerative disk disease, l5-s1.2.Central disk herniation, l5-s1.3.Foraminal stenosis, l5-s1.Procedures performed: 1.Transforaminal lumbar interbody fusion, l5-s1.2.Posterolateral lumbar fusion, l5-s1.3.Decompression with hemilaminectomy and total facetectomy left l5-s1.4.Pedicle screw instrumentation, bilateral l5 and s1.5.Application of intervertebral biomechanical device, l5-s1.6.Harvest of posterior iliac crest bone graft from a separate incision.7.Intraoperative neuromonitoring.Pedicle screws, interbody machined allograft spacer, rhbmp-2 bone morphogenic protein were used.Per-op notes: at l5 on both sides, we placed 6.5 mm in diameter x 45 mm in length pedicle screws and at s1, we placed 6.5 mm in diameter x 40 mm in length pedicle screws.On the right side, a large quantity of combined bone graft mixture into the right posterolateral gutter was packed.The bone graft mixture included harvested iliac crest autograft, bone morphogenic protein, and morselized allograft cancellous chips.Following annulotomy, total diskectomy at ls-s1 was carried out.Then l5 and s1 endplates were prepared for interbody fusion.Then, a combination of iliac crest autograft, bone morphogenic protein, and morselized allograft chips was packed.With the bone graft construct in place, a 12 mm in height machined allograft interbody spacer into the intervertebral space was impacted centering it over the junction of the middle and posterior thirds.(b)(6) 2009: the patient presented for a follow up.(b)(6) 2009: the patient presented with post op evaluation.Diagnosis: 1.Six weeks status post tlif l5-s1.2.Opioid dependence.3.Continued smoker.(b)(6) 2009: the patient presented with post decompression and fusion l5-s1, low back pain and left lower extremity pain.The patient underwent x-ray of lumbar spine and shows interbody fusion at l5-s1 with posterior hardware.Graft and hardware is intact and in place without migration or signs of loosening.Diagnosis: 1.Status post tlif l5-s1.2.Leg length discrepancy of 2.66 cm, right leg longer than left.3.Tobacco use.(b)(6) 2009: the patient presented with back pain.Diagnosis: insomnia, other abnormal glucose, sciatica, anxiety (b)(6) 2009: the patient presented with back pain.Assessment: insomnia, chronic low back pain, sciatica, anxiety (b)(6) 2009: the patient presented with post decompression and fusion l5-s1.Diagnosis: 1.Status post tlif l5-s1 with improving symptoms.(b)(6) 2010: the patient presented for recheck.Diagnosis: 1.One-year status post tlif l5-s l 2.Low back pain 3.Left rotator cuff tendinosis.(b)(6) 2013: the patient presented for an office visit.Diagnosis: anemia, excessive or frequent mensuration, mild intermittent asthma, elevated blood pressure reading without diagnosis of hypertension, headache, anxiety.

• 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: 5101206
• MDR Text Key: 26788359
• Report Number: 1030489-2015-02430
• 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
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110801AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2008
• 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