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 Neuropathy (1983); Pain (1994); Numbness (2415)

Event Date 09/12/2011

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.

Event Description

It was reported that on (b)(6) 2011, patient was admitted to the facility where surgeon performed spine fusion surgery using rhbmp2 on the lumbar region of her spine from vertebrae l2 to l5.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.Post-op, patient reportedly had "increasing low back pain, with radiation into her buttock region bilaterally and her right posterior thigh, with numbness throughout her right leg"."severe pain and symptoms ultimately led to a revision surgery on (b)(6) 2012.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with the following pre-op diagnosed: lumbar spondylosis, spondylolisthesis, and rotatory scoliosis.He underwent the following procedures: l2,l3 decompressive laminectomies, t11-t12, t12-l1, l1-l2 bilateral facetectomies, deformity correction, l2-l3 interbody fusion with autologous local bone, interbody ramps, bone morphogenic protein, posterior lateral fusion t11- l3 bilaterally with autologous local bone and chronos strip and autologous bone marrow aspirate, t11-l4 pedicle screw fusion with pedicle screw instrumentation, exploration of fusion at l3-l5, removal of l3 through l5 pedicle screw instrumentation.As per the operative notes,¿ autologous local bone harvested from the laminectomies was morcellated and packed densely into the interspace on one side, followed by a lordotic allograft ramp filled with a sponge soaked in bone morphogenic protein.The ramp was impacted into the interspace from one side until it was recessed ventral to the posterior cortex at l2 and l3.From the contralateral side, additional autologous bone was packed into the interspace, followed by a second bmp filled interbody ramp¿.No intra-operative complications were reported.

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with the following pre-op diagnosed: lumbar spondylosis, spondylolisthesis, and rotatory scoliosis.He underwent the following procedures: l2,l3 decompressive laminectomies, t11-t12, t12-l1, l1-l2 bilateral facetectomies, deformity correction, l2-l3 interbody fusion with autologous local bone, interbody ramps, bone morphogenic protein, posterior lateral fusion t11- l3 bilaterally with autologous local bone and chronos strip and autologous bone marrow aspirate, t11-l4 pedicle screw fusion with pedicle screw instrumentation, exploration of fusion at l3-l5, removal of l3 through l5 pedicle screw instrumentation.As per the operative notes,¿ autologous local bone harvested from the laminectomies was morcellated and packed densely into the interspace on one side, followed by a lordotic allograft ramp filled with a sponge soaked in bone morphogenic protein.The ramp was impacted into the interspace from one side until it was recessed ventral to the posterior cortex at l2 and l3.From the contralateral side, additional autologous bone was packed into the interspace, followed by a second bmp filled interbody ramp¿.No intra-operative complications were reported.

• 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: 6025066
• MDR Text Key: 57249693
• Report Number: 1030489-2016-02866
• 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,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: 09/19/2016; 03/26/2018; 03/26/2018
• Supplement Dates FDA Received: 09/25/2017; 04/16/2018; 04/18/2018
• 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): Required Intervention
• Patient Age: 68 YR