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

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

Patient Problems Ossification (1428); Inflammation (1932); Neuropathy (1983); Pain (1994); Swelling (2091); Dysphasia (2195); Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported that the patient underwent a c5-c6 bilateral laminectomy with fusion using competitor screw system, bone morphogenic protein, and spinal microdissection.Reportedly, sometime post-op, imaging studies showed that the patient had developed uncontrolled bone growth and nerve compression at or near where rhbmp-2/acs was implanted.The patient experienced uncontrolled or ectopic bone growth, cervical spine pain, swelling of airways, difficulty speaking, inflammatory reactions, pain to other parts of her body, chronic pain and radiculitis.

Manufacturer Narrative

Concomitant medical products: synthes lateral mass screw system (implant (b)(6) 2010; explant unknown).(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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.

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) 2010: the patient was pre-operatively diagnosed with cervical stenosis and instability and underwent the following procedures: posterior c5-c6 bilateral laminectomy with fusion using synthes lateral mass screw system, bone morphogenic protein, spinal microdissection.As per op-notes, ¿bone morphogenic protein was then used to perform facet fusion after the area was decorticated.¿ no patient complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4270307
• MDR Text Key: 5230428
• Report Number: 1030489-2014-04506
• 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,consumer
• Reporter Occupation: Attorney
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• 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