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 Abscess (1690); Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Swelling (2091); Stenosis (2263); Injury (2348); Neck Pain (2433)

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

Per medical records, it was reported that on (b)(6) 2006: patient underwent lumbar spine x-ray which demonstrated no significant translocation on flexion or extension.(b)(6) 2007: patient underwent lumbar esi.(b)(6) 2007: patient presented with back pain status post a fall into a water meter hole with back pain about a week ago and right hand dominance.Patient had numbness and tingling in her right leg.She had a lumbar esi that did not help.Patient had burning down her right leg since the esi.System review was positive for back pain.Lumbar was mild tender.There was positive sle.Assessment: back pain, lumbar; spondylolisthesis (b)(6) 2007: patient was admitted with chief complaint of back pain.Pre-op diagnoses: grade 1 spondylolisthesis at l5-s1.Patient underwent l5-s1 transverse lumbar interbody fusion at l5-s1 from the right.Procedure was carried out under fluoroscopic guidance.Per op notes, good decompression was achieved.Then bone morphogenic protein soaked sponge was placed in the disk space and morselized bone obtained from the lateral mass on the right.It was placed over the sponge and then packed it into position.Then, a 9 mm leopard cage was inserted and went into good position with a good firm fit and distraction and significant reduction.A 55 mm screw was inserted at l5 and 50 mm screw inserted at s1.A 40 mm rod was then used to connect the polyaxial heads together and they were x-rayed and found to be in good position in the ap and lateral views.No complications reported.(b)(6) 2007: patient underwent ct lumbar spine.Impression: 1.Interval postoperative changes from right posterior fusion at the l5-s1 level and right laminectomy at the l5 level.The hardware appears in good position.2.Grade 1 anterolisthesis of l5 on s1.Left spondylolysis at the l5 level.Mild to moderate left neuroforaminal stenosis at the l5-s1 level.(b)(6) 2007: patient was discharged.On an unknown date in (b)(6) 2007, patient presented with abscess and underwent exploratory incision and debridement of the wound.(b)(6) 2007: patient presented for post-operative follow up with right leg numbness.Patient stated that she gets to where she could not have her right leg at times.Patient was kicked by her daughter once in the right side and once on the left side and had to go to the er 3 times due to her pain.Patient's wound was healing well.(b)(6) test was positive for right lower extremity.Assessment: patient was doing fine but had musculoskeletal pain.Patient underwent lumbosacral x-ray status post tlif.Impression: 1.Intervertebral and right unilateral fusion at l5-s1.2.Persistent grade 1-2 spondylolisthesis.(b)(6) 2007: patient presented for post operative follow up.Plain x-rays and (ct) computerized tomography of the spine showed what appears to be good progression and fusion without any signs of bony erosion.Good position of the hardware.No perivertebral phlegmon or abscess noted.Alignment is good.Impression: a subcutaneous infection or hematoma.Patient underwent lumbosacral x-ray status post tlif.Impression: status post posterior fusion at l5-s1 with right-sided transpedicular screw-plate apparatus.Stable anterior subluxation at the level of fusion.Otherwise no acute fracture or subluxation.Mild scoliosis which may be positional.(b)(6) 2007: patient fell and injured her right foot.(b)(6) 2007: patient presented for follow up of l5-s1 tlif and soft tissue infection.Patient reported right foot pain and there was ace wrap on the foot.There was mild swelling of the right foot.Back wound has healed very well.Lateral and ap lumbar spine x-ray showed clear sharp bone edges.Good position of hardware.No change in the tlif appearance.Patient underwent lumbosacral x-ray status post tlif and staph infection.Impression: status post posterior fusion at l5-s1 with right-sided transpedicular screw- plate in position.There is subluxation of l5 on s1.The findings appear unchanged from the exam of (b)(6) 2007.(b)(6) 2007: it was reported that the patient was in the swimming pool and was hit in the back and bled from her back wound which previously had been healed up.(b)(6) 2007: patient presented for follow up of superficial back infection.Patient had some serous drainage from it and occasional episodic spotting of blood.She also has a cold feeling in her spine that shoots up toward her neck at times for the past two weeks.She started having loss of bladder control since the accident.The deep back pain she was having prior to surgery was better.Review of systems was positive for back pain.Ct of lumbar spine showed good fusion at l5-s1, good position of hardware and no fluid collection around the hardware or the bone.Good fat planes around l5-s1 area.Impression: superficial wound infection that keeps recurring.Needs surgical incision, drainage, debridement, and closure.Patient underwent ct lumbar spine without contrast.Impression: 1.Postsurgical changes on the right at l5-s1 are again noted.When compared to the prior study, there has been an interval increase in irregularity/indistinctness of the opposing endplates at this level, such that change of discitis cannot be excluded.Clinical correlation would be helpful.Otherwise, no significant interval change is seen in the appearance of the lumbar spine and the post surgical changes at l5-s1.Patient also underwent ct coronal.(b)(6) 2008: patient presented with neck and back pain.Patient was in her usual state of chronic pain that pre-existed even the first back surgery.When patient fell two weeks ago and landed on her tail bone and hit the back of her head a little bit on the right she didn't lose consciousness but has tailbone pain as the worst pain, then neck pain and headaches as her second worse pain.Patient was slightly tender in the right mid cervical spine.Ct of lumbar spine showed good fusion at l5-s1.No evidence of infection.Mri of cervical spine showed plenty of room for the spinal cord and mild left c4-5 neural foraminal narrowing, otherwise open foramen.Impression: lumbago, cervicalgia without radiculopathy or myelopathy.Patient underwent mri cervical spine.Impression: mild spondylotic changes.No significant cervical stenosis or cord encroachment.Moderate left neural foraminal narrowing at c4-c5.Normal cervical spinal cord.Patient underwent ct lumbar spine without contrast.Impression: status post fusion at l5-s1 with stable grade i spondylolisthesis.Otherwise no acute fracture or subluxation.Stable mild endplate irregularity at the l5-s1 level likely reflecting postsurgical changes.Non-obstructing right renal calculus.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5049263
• MDR Text Key: 24822831
• Report Number: 1030489-2015-02171
• 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
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2009
• Device Catalogue Number: 7510200
• Device Lot Number: M110604AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Date Device Manufactured: 01/31/2007
• 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): Other
• Patient Weight: 117