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 Device Operates Differently Than Expected (2913)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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) 2007, the patient presented with complaint of neck pain, numbness and spasms.The mri also revealed a posterior c5-6 posterior osteophyte spur and a small disc herniation c6-7 with associated bilateral neural foraminal stenosis.On (b)(6) 2007, the patient presented for office visit with failed conservative treatment.On (b)(6) 2007, the patient presented with a complaint of umbilical hernia.Impressions: umbilical hernia.On (b)(6) 2007, the patient underwent a surgery with diagnosis of cervical posterior disc osteophyte fusion at levels c5-6 and c6-c7.Per op-notes, the wound was thoroughly irrigated with antibiotic containing saline.A pcr p-cage filled with bmp sponge measuring 11x14 mm was then placed in the interspace while in slight distraction, distraction was released.A plate was placed from c6 to 7, 15 mm screws were used and screws were locked down to the plate using locking mechanism on the plate.Good hemostasis was achieved prior to closure.The patient also underwent another surgery with diagnosis of umbilical hernia where umbilical hernia repair with ventralex mesh was performed.On (b)(6) 2007, the patient was discharged with a diagnosis of c6-7 posterior disk osteophyte complex.The patient had no complications.On (b)(6) 2008, the patient presented for a follow-up.On (b)(6) 2012, the patient presented with a complaint of back pain and pain in right leg., numbness limited range of motion, sciatica the patient twisted his back while pulling cart.The mri of the patient revealed severe spinal stenosis l3-4-5 and a disc herniation l3-4 and right far lateral l4-5.On (b)(6) 2012, the patient underwent a surgery with diagnosis of lumbar spinal stenosis, lumbar disk herniation and l3-l4 spondylolisthesis.Operative procedure: 1) decompression at l3-4, l4-5.2) pedicle screw fixation l3-l5.3) posterolateral fusion l3-l5.Posterior inter-body fusion l3-l4, l4-l5.Resection of lateral recess stenosis over exiting right and left l3, l4, l5 roots.6) cage placement posteriorly l3-l4, l4-l5.7) use of frameless stereotactic guidance for pedicle screw placement.Per op-notes, at the time, a complete facetectomy was then performed, also at l3-l4 bilaterally.Peek cages measuring 10 x 22 mm were filled with autologous bone graft and then placed into the interspaces to the right and left of the dura at l3-l4, l4-l5.Lateral facet joints were then decorticated bilaterally l3-l4, l4-5.Using frameless stereotactic guidance, pedicle screws were place at l3, l4 and l5.Following screw placement, intraoperative o-arm cat was obtained which revealed good screw positioning within the pedicles and good cage positioning.Rods were then fashioned and secured to the screw heads.A crosslink was placed between the right and left rod.The wound was tho roughly irrigated with antibiotic-containing saline.At no time was there any evidence for csf leak.Good hemostasis was achieved prior to closure.Further autologous bone graft was placed in the posterolateral gutters from l3-4 to l4-5.On (b)(6) 2012, the patient presented with a complaint of pain in left leg l3.On (b)(6) 2012, the patient underwent x-rays and mri that revealed small annular tear at l5-s1, foraminal narrowing right l2-3.On 08 mar 2012, the patient presented for a follow-up.On (b)(6) 2012, the patient presented with complaint of pain in left leg due to l5-s1 annular tear.On (b)(6) 2012, the patient presented for a follow-up with disability related to his back with a chronic pain disorder.On (b)(6) 2013, the patient presented with a follow-up with complaints of lower back pain, bilateral leg pain mainly in l2 distal region and numbness in right foot.

• 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; mmphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5042729
• MDR Text Key: 24634496
• Report Number: 1030489-2015-02123
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110701AAF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2007
• 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