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

Catalog Number 7510100

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

Patient Problems Neuropathy (1983); Pain (1994); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

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, the patient underwent posterolateral lumbar fusion surgery on the lumbar region of his spine from vertebrae l3 to s1.Reportedly, he was implanted with rhbmp-2/acs in this surgery.The rhbmp-2 collagen sponge was placed outside a cage, i.E., in the disc space and posterolateral gutters.Allegedly, the patient's "post-operative period was marked by a period of improvement, followed by increasingly severe low back pain, with pain and radicular symptoms into his legs, buttocks, groin and feet." the patient underwent revision surgery on (b)(6) 2015, due to severe pain and symptoms.Reportedly, the patient "continues to experience constant and low back pain radiating to his right buttocks and right leg, and numbness and tingling in his right foot.Patient also experiences sexual dysfunction." reportedly, the patient uses a walker to assist in ambulation.

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.

Manufacturer Narrative

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

Event Description

It was reported that the patient was pre-operatively diagnosed with degenerative joint disease at l3-l4, l4-l5 and l5-s1 and underwent the following procedure: anterior exposure for discectomy and bone fusion l3-l4, l4-l5, and l5-s1.The patient was pre-operatively diagnosed with l3-l4, l4-l5, and l5-s1 disc degeneration with discogenic pain and underwent the following procedures: 1) l3-l4, l4-l5 and l5-s1 anterior lumbar interbody fusion with allograft and bone morphogenic protein.2) placement of interbody fusion device at l3-l4, l4-l5 and l5-s1 including a polyether ether ketone cage.3) posterior instrumentation l3-s1 with pedicle screws and rods.4) posterolateral arthrodesis l3-s1 with allograft and bone morphogenic protein.5) stealth navigation.As per op-notes,¿ a 10mm x 8 degree graft was sized and then placed, packed with allograft and bone morphogenic protein, with extra bone and bmp used for complete arthrodesis of the disc space.The next level was l3-l4 with a similar procedure carried out and finally at l4-l5.Patient is a known vasculopathy with stents in place and there was significant retraction throughout the case.The other surgeon confirmed blood flow to the lower extremities prior to closing, per his separately dictated note.C-arm imaging and ap and lateral views were used throughout the procedure to confirm levels, as well as implant placement.Following placement of grafts and closure, patient was repositioned in the prone position on a frame after which patient was prepped and draped in the usual sterile fashion, and another surgical timeout as well as reducing antibiotics was conducted.Following this, a midline incision extending from the spinous process of l2 to the sacrum with elevation of muscular flap up off the lamina of l3, l4, l5, and s1 out onto the transverse process and ala respectively.Following this exposure fiducial reference frame was placed at l5, and o arm was brought in for image data acquisition after which placement of pedicle screws with 7.5mm x 45mm screws placed bilaterally was done at l3, 7.5 x 45 on the left, 8.5 x 40 on the right at l4, 8.5 x 50 bilaterally at l5, 8.5 x 40 bilaterally at s1, with the s1 screws being bicortical.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6025063
• MDR Text Key: 57249327
• Report Number: 1030489-2016-02864
• 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: 12/20/2017

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: 02/01/2012
• Device Catalogue Number: 7510100
• Device Lot Number: M111055AAA
• 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; 12/27/2017
• Supplement Dates FDA Received: 09/25/2017; 12/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2010
• 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): Required Intervention