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

Catalog Number 7510800

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

Patient Problems Fatigue (1849); Malaise (2359); Respiratory Failure (2484)

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) 2007, the patient presented after motor vehicle accident and diagnosed of central cord syndrome.(b)(6) 2007, the patient diagnosed with c6-7 fracture dislocation and underwent c4-t2 instrumentation with c6-7 laminectomy.C4 to t2 posterior arthrodesis with c4 to t2 spinous process wiring and lateral mass and pedicle screws.Morselized allograft, local allograft and open reduction of fracture dislocation.During the procedure, the superior articulating facets of c7 were then drilled down bilaterally with a high speed drill.Using an angled curet the inferior portions of the c6 articulating facets bilaterally were elevated until they were realigned with the superior portion of the c7 facets back into their anatomic position.Once this was completed attention was then turned toward instrumentation.Lateral mass screws were placed in on the right at c4, c5 and c7.Pedicle screws were placed in t1 and t2 on the right side.On the left side c4, c5, c6 and c7 lateral mass screws were placed and t1 and t2 pedicle screws were placed.This was subsequently connected with a 110 mm rod bilaterally.The areas were then copiously irrigated and hemostasis was achieved.Bmp with local autograft and morselized allograft were then placed in the lateral gutters after decortication was completed.Again hemostasis was achieved and the area was copiously irrigated.Attention was then turned toward closure.No intra-op complications noted.(b)(6) 2007, the patient presented with preoperative diagnosis of respiratory failure.Trachcotomy was performed (b)(6) 2012, the patient presented for ct-sinus/facial bones wo contrast.Impression: no evidence of paranasal sinusitis at this time.There is leftward bowing of the nasal septum and apical spurring.(b)(6) 2013, the patient presented for xr-chest pa <(>&<)> lat after complaining of malaise and fatigue.Impression: no acute cardiopulmonary process; 2.Age indeterminate lower thoracic vertebral body compression fracture (b)(6) 2013, patient visited for ultrasound-transrectal.Impression: benign prostatic hypertrophy with no distinct evidence of masses.

• 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: 5091194
• MDR Text Key: 26305229
• Report Number: 1030489-2015-02442
• 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: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510800
• Device Lot Number: M110803AAH
• 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
• 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