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 Ossification (1428); Muscle Spasm(s) (1966); Pain (1994); Seroma (2069); Swelling (2091); Weakness (2145); Injury (2348)

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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on: on (b)(6) 2011: the patient presented with following pre-operative diagnoses: failure of previous lumbar fusion, t3-l4 with subsequent l4 vertebral body and pedicle fracture.Post fracture kyphosis and loss of sagittal balance and progressive post fracture scoliosis l3-4 status post deformity and postsurgically related fracture l4.Postsurgical kyphosis and degenerative disk disease with associated possible intermittent spinal cord compression due to mobile kyphosis t2-t3.Patient being status post revision instrumentation with removal of previously placed hardware t3-l4 with re-instrumentation c7 to the pelvis performed on (b)(6) 2011.The patient underwent the following procedures: completion of pedicle subtraction osteotomy l4.Transverse lumbar interbody fusion for stabilization of progressive generative disk disease, l3-4.Completion of instrumentation and fusion c7 to the pelvis with local bone grafting.Per op notes, bone grafting was performed after decortication of the cervical and thoracic spine from c7 down to approximately t6, posterior allografting was then performed using a combination of local bone, beta tricalcium phosphate and bone morphogenic protein placed directly over the exposed decorticated surfaces bridging the area.Similar grafting procedure was then done of the lumbar spine from approximately from the fusion mass of the lumbosacral junction up into the upper lumbar spine at approximately t12-l1.With posterior grafting completed bilaterally at each junctional segment, the surgical wound was then irrigated and then closed.There were no known patient complications.Postop patient continues to suffer from daily severe and disabling pain in her back, weakness in her upper extremities, abnormal bone growth, a large swelling at the cervicothoracic spine, and the appearance of solid nodules of unknown etiology in her lungs.

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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6092042
• MDR Text Key: 59555080
• Report Number: 1030489-2016-03124
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2013
• Device Catalogue Number: 7510600
• Device Lot Number: M110909AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2010
• 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: 56 YR
• Patient Weight: 104