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 Pain (1994); Stenosis (2263); No Code Available (3191)

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.Products from multiple manufacturers 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) 2009: the patient was preoperatively diagnosed with degenerative disc disease, lumbar spine, greatest at l4-l5,l5-s1.Status post laminectomy, discectomy x2 or 3.Debilitating back and left leg pain.New herniation left l4-l5 and underwent following procedures: anterior lumbar interbody fusion l4-l5, l5-s1 with anterior fixation of both l4-l5 and l5-s1 using plate and 4-hole plate.As per op-notes" we trialed the various sizes, 14 mm cage was chosen with bmp and bone graft matrix placed centrally and also bmp laterally with bone graft laterally as well as bone graft placed anteriorly where it was countersunk slightly, we used the 12 mm cage with 'bmp and bone graft identically to the superior level.We next applied a plate at the l4-l5 level which we could sneak in below the bifurcation and a 4-hole plate the l5-s1 level.We used platelet overlying the plates." the patient was preoperatively diagnosed with status post anterior lumbar interbody fusion l4-s1.Degenerative disk disease l4-l5, l5-s1.Status post previous laminectomy and discectomy x2 or 3 at l4-l5, l5-s1.Debilitating back and left greater than right leg pain and underwent following procedures: l4-l5 and l5-s1 posterior spinal instrumented fusion using a right sided pedicle screw instrumentation, bone morphogenic protein and a combination of local autograft/allograft.Left l4-l5 and l5-s1 hemilaminectomy and exploration of the disc space.As per op-notes" on the right side we created intralaminar fusion and interfacet fusion on the right side posteriorly using combination of a small kit of bmp and bone graft".On (b)(6) 2010: the patient was preoperatively diagnosed with degenerative disc disease, lumbar spine.Status post previous l4-sl laminectomy and fusion.Residual bilateral lower extremity pain and back pain.Painful hardware.Mild adjacent level stenosis l3-4 and underwent following procedures: removal of hardware and exploration of fusion l4 to s1 including augmentation of fusion with demineralized bone matrix.Bilateral l3 and l4 hemilaminotomy and foraminotomy revision.As per op-notes" we exposed all of the screws at each level, removed each of the screw heads, rod and pedicle screws at each level, explored the fusion mass appeared to be intact except for some incomplete healing across the l4-l5 level posteriorly.".

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: 5700057
• MDR Text Key: 46563098
• Report Number: 1030489-2016-01639
• 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
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110711AAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2008
• 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