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 Pain (1994); Stenosis (2263); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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 reported device contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported per patient's medical records that on: (b)(6) 2017: patient came for follow up.Radiology: mri lumbar spine reviewed by me demonstrating synovial cyst formation l3-4 with significant facet arthropathy l3-4 as well as stenosis at l5-s1 and stenosis at l2-3 ct scan lumbar spine shows good intact instrumentation with evidence of facet arthropathy l3-4 as well as coronal deformity and loss of normal lordosis with an apex at l3.The patient presented with the following pre-op diagnosis: junctional stenosis in the lumbar spine.Lumbar degenerative scoliosis.Synovial cyst.The patient underwent following procedures: direct lateral interbody fusion at l2-l3, l3-l4 with peek interbody allograft and neuro monitoring posterior revision with reinsertion of lumbar instrumentation, l3-l4 laminectomy for resection of synovial cyst, l2-pelvis fusion with autograft, posterior instrumentation and neuro monitoring with o-arm/stealth approach.As per operative notes, ¿i prepared the endplates appropriately, with assistance from the mid-level provider providing soft tissue retraction and neural structure retraction as needed.I also performed a contralateral release.I then placed various sizes of interbody templates and decided to place a 12 millimeter by 50-millimeter graft.I copiously irrigated the disc space.I confirmed adequate preparation of the disc space and took a peek graft with a small amount of bone morphogenic protein and bone graft.With the assistance of the mid-level provider providing important soft tissue retraction, i implanted this under fluoroscopic guidance and removed the applicator.The graft was in satisfactory position.I copiously irrigated with antibiotic irrigation.The anchoring pen was then removed, and the tubular retractor removed.I inspected the retroperitoneal on removing the retractor.No obvious intra-abdominal or retroperitoneal injuries.I then placed deep self-retaining retractors.I started by placing bilateral pelvic screws.My mid-level and i placed the bilateral pelvic screws under stealth guidance using 8.5 by 90 millimeter screws.I then focused my attention on pedicle screws.I decided to place bilateral screws at l2, l3.I used 6.5 millimeter screws.I left the l4 and l5 screws and placed.The mid-level provider assisted me and placing all the instrumentation with both handling of the instrumentation as well as retraction of soft tissue.I tested each screw with emg with thresholds above the accepted minimal.I then copiously irrigated with antibiotic irrigation.The exposed bony surfaces of the facet joints and proximal transverse processes were already decorticated during the laminectomy in preparation for the arthrodesis.I took 2 precut rods placed the appropriate amount of curvature and affix them to the pedicle screws using set screws.I used interconnectors for the pelvic instrumentation.A cross-link x2 was also placed.The mid-level provider broke the heads of the set screws off.I then removed the self-retaining retractors." no patient complications were reported.On (b)(6) 2019: the patient presented with the following pre-op diagnosis: spinal instabilities of lumbosacral region.Acute low back pain, unspecified back pain laterally, with sciatica presence unspecified.Spinal stenosis.The patient underwent following procedures: removal of posterior lumbar pelvic instrumentation, l1-l2 decompressive laminectomy, foraminotomy, lumbar 1- lumbar 3 posterior fusion with posterior instrumentation, autograft and intraoperative neuromonitoring.As per operative notes, ¿i exposed laterally to the posterior instrumentation and exposed this in its entirety from l2 to pelvis.I then used the appropriate removal system and removed the set screws followed by the rods.The mid-level provider assisted with all instrumentation handling and removal.I then removed the pedicle screws at the l4 and l5 levels as well as the pelvic screws.The left-sided rod was noted to be fractured just proximal to the pelvic interconnectors.At this point i used a high-speed drill to drill the lamina and medial facets of the level rostral to the instrumentation at l1-2.There was clear-cut instability at l1-2.I completed this bony work using a kerrison rongeur.I then focused on posterior lateral instrumentation.I placed pedicle screws at l1.I used instrumentation.I placed the pedi cle screws under fluoroscopic guidance.I then stimulated the screws with emg to make sure there was no abnormal nerve stimulation.I then took 2 precut pre-bent cobalt chrome rods and affix them to the l1, l2 and l3 pedicle screws using set screws.I then broke the heads of the set screws with the torque counter torque device.I then irrigated once more.I then took locally harvested autologous bone graft combined with a small amount of vancomycin powder and placed it over the decorticated surfaces from l1 to l3." no intra-operative complications were reported.

Manufacturer Narrative

Radiological images review: post-operative ct/mr and post op revision ct provided for l2-iliac fusion.On pre-op images, there is an l4-5 stenosis without level deformity.On the post review ct, a rod fracture is evident on the left side at l5-s1.Interbody grafts are present at l2-l3, l3-l4, l4-l5 with varying degrees of bony growth.There is no obvious lateral fusion mass anywhere else and without bony fusion at lumbosacral junction, this is a likely point for hardware failure.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8834610
• MDR Text Key: 152497086
• Report Number: 1030489-2019-00834
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843782
• UDI-Public: 00681490843782
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 7510200
• Device Lot Number: M111701AAQ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/28/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2017
• 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