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 Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Injury (2348); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Note: 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.Multiple products 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 (b)(6) 2012, the patient underwent posterior spine fusion surgery on the cervicothoracic region of her spine from vertebrae c6 to t1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed with cage in the facets and lateral gutters.Post-op, the patient suffered from increasing severe neck pain and swelling, with radiating pain to her mid back, and radiculopathy in her upper extremities.She continues to experience chronic neck pain, with radiating pain to her mid back, and swelling and stiffness in her neck.She has limited range of motion in her neck, limited mobility due to pain, and experiences difficulty sleeping.

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) 2012: the patient was preoperatively diagnosed with cervical spondylosis with myeloradiculopathy, c3-t1 and underwent the following procedures: posterior cervical laminoplasty of c4, 5, 6, 7 with right foraminotomies at c5-6, c6-7, c7-t1 with placement of laminoplasty plates at all four levels.Posterior cervical fusion of c6-7.Posterior cervical fusion additional level c7-t1.Posterior cervical segmental instrumentation c6-7 and t1 with instrumentation.Local autologous bone plus demineralized bone matrix plus small bmp onto a 5 cc block grafting.Microscope visualized laminoplasty foraminotomies.Partial laminectomy of the inferior 75% of c3 without facetectomy or foraminotomy.As per the op notes, "we decorticated the facets at c6-7 and c7-t1 bilaterally and packed in local autograft and a graft block that was soaked onto bmp and put it in into the facets and into the lateral gutters.We added local autograft and demineralized bone matrix.We obtained an x-ray and because of the short neck and the area that we were dealing with, the lateral x-ray just showed the top end of the construct and we couldn't really visualize the t1 despite trying a maximal exposure.We put in additional and remaining bmp, put in hemostatic agents, deep and superficial drains, and carefully closed the wound in layers.¿.

• 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: 5744155
• MDR Text Key: 47995547
• Report Number: 1030489-2016-01858
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111101AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2011
• 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 Age: 52 YR