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

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

Patient Problems Headache (1880); Pain (1994); Numbness (2415)

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.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.

Event Description

It was reported that on (b)(6) 2006: patient was presented with pre-op diagnosis : l5 spondylolysis with grade i spondylolisthesis.For which patient underwent direct pars.Repair, l5.Post-op, there is a small rod that extends from the l5-s1 level.As per op note, anatomic landmarks were visualized and an awl was used to gain access to the pedicle.A 5.0 x 40 mm pedicle screw was then placed into both pedicles.Position was also again viewed in the ap and lateral planes to ensure proper positioning.Rhbmp-2 mixed with allograft was placed within the decorticated pars defects.Patient tolerated the surgical procedure without any complication.On (b)(6)2006: patient was diagnosed with back pain.On (b)(6) 2006: the patient underwent x rays of the lumbar spine.Findings: the screws which extend through the pars articularis bilaterally at l5 appear stable.There is a small rod that extends from the l5-s1 level.Subtle lucency is present along the inferior articulating facets of this rod at the s1 level.This is similar to prior study.Amorphous density dorsal to the rod is most consistent with bone graft.Mild bony demineralization is questioned.Mild to moderate bowel gas distention.On (b)(6) 2008: clinical information: left knee pain, limping.On (b)(6) 2008: patient was pre-operatively diagnosed with cervicalgia.On (b)(6) 2011: patient underwent mri of cervical spine without contrast with 3d attn.Conclusion: 1) no evidence of c1-2 instability on dynamic views.2) mild luschka joint hypertrophy at c4-5.No acute soft disc extrusions or compressive discopathy.3) no intrinsic abnormality of cervical spine cord.4) no evidence of unstable ligamentous injury.(b)(6) 2009: the patient underwent "mr - temporomandibular joints due to difficulty with opening the mouth, joint pain, muscle spasms and headache.Conclusion: partial derangement of the tmjs bilaterally with limited range of motion or anterior translation of the mandibular condyles with open-mouth positioning.On (b)(6) 2009: clinical history: chronic headache.Assess for disc disease.(b)(6) 2009:patient had muscular/ligamentous pain coming from the cervical spine.(b)(6) 2010: complaints of pain to upper back and neck.(b)(6) 2011: mild joint hypertrophy at c4-5.(b)(6)2012: the patient presented with the following preoperative diagnoses: 1.Rotatory instability, c1-c2.2.Ehlers-danlos syndrome.3.Hypermobility syndrome causing c1-c2 rotatory instability with symptoms of cervicomedullary syndrome.She underwent the following procedures: 1.C1-c2 posterior spinal instrumentation (c1 isthmus, c2 pedicle screw).2.Posterior spinal fusion using auto and allograft c1-c2.Depuy rods and screws, integra graft, alpha scientific allograft puregen and profuse chips were used in this surgery.As per the op notes, ".The lamina of c1 and the lamina of c2 were completely decorticated, packed with auto and allograft along the osteo-regenerative cells.Local bone was harvested.It was also mixed with the allograft as well.This gave an excellent fusion bed."no patient complications were reported.(b)(6) 2012: patient underwent x-ray of cervical spine which shows a right sided screw in c12 isthmus and c2 pedicle.Both screws seems to be well in place.The lateral adj on the right and the left seems to be well within physiological range.Flexion/extension images don't show evidence of either occiput-0c1 or c2-c3 instability.Impression: stable appearances status post c1-c2 posterior instrumented spinal fusion.(b)(6) 2012: patient underwent mri of cervical spine without contrast for evaluating hardware as patient has trouble ambulating and numbness in both legs.Conclusion: 1) status post c1-2 screw fixation without bony bridging.Aspect ratio distortion limits right foraminal and vertebral artery assessment.The right c2 screw on the oblique images may traverse the course of right vertebral artery, however, vertebral artery flow voids above and below this level appear intact.On (b)(6) 2012: patient was diagnosed with l5-s1 facet arthrosis.On (b)(6) 2012: patient underwent mri of lumbar spine without contrast due to low back pain.Conclusion: 1) shallow non-compressive protrusion at l4-l5.2) status post l5 transpedicular and pars fixation without bony bridging.(b)(6) 2012: patient presented for evaluation and is complaining of low back pain.Patient is tender in lower spine around the lumbosacral junction.Forward flexion and extension both seem to be painful, extension more painful.She has sensory paresthesias in the l5 distribution bilaterally.Mri of lumbar spine was reviewed which show that l5-s1 disk seems to be well preserved at this point.There is evidence of previous hardware which seems to be well in place.The overall l5-s1 foraminal seems to be patent at this patent.There is evidence of facet arthrosis at the l5-s1 level.Impression: l5-s1 facet arthrosis.On (b)(6) 2012: patient underwent ct of lumbar spine without contrast due to low back pain.Conclusion: 1) status post l5 transpedicular and pars hook fixation.Pars defects may be bridged in correlation on multi planar views.There is mild retrolisthesis of the l5 on s1.2) l4-5 right lateral disc displacement abuts the right l5 root and more conspicuous than on mri of (b)(6) 2012.3) right l5 pedicle screw slightly medially placed.(b)(6) 2013: the patient presented with neck pain along hairline.She also complained of headaches with neck pain.(b)(6) 2013: patient underwent ct of cervical spine without contrast due to neck pain, headache with flexion/extension and assess for c1-c2 bony fusion.Conclusion: 1) no bony bridging across c1-2.Status post right c1-c2 transpedicular fixation.(b)(6) 2013: the patient presented with neck pain and headaches.She also had some limited mobility of her cervical spine.Ct san of cervical spine was reviewed that showed evidence of the lateral mass screws and excellent position of the c1-2 level; however, there appeared to be a halo around the c2 screw, possibly indicating loosening or lack of fusion.(b)(6)2013: the patient underwent mri of cervical spine due to cervical radiculopathy, bilateral shoulder pain and history of c1-2 fusion.Conclusion: status post right sided c1-2 screw fixation without bony bridging; no acute soft disc extrusions or compressive discopathy; no sever central canal stenosis; no spinal cord gliosis or syrinx formation.(b)(6) 2013: the patient presented with neck pain.(b)(6) 2013: the patient underwent x-rays of the lumbar spine due to lumbago.Impression: mild degenerative changes of the lumbar spine.(b)(6) 2013: the patient presented with the following preoperative diagnosis: pseudoarthrosis c1-2.She underwent the following procedure: removal of lateral mass screws at c1-c2 right.As per the op notes, scar tissue was sharply dissected on the right, the screw heads were exposed.The construct was moving freely in the scar tissue confirming the pseudoarthrosis.The lock caps were then removed.Then the rod was removed, and then each screw was removed¿no patient complications were removed.(b)(6) 2014: the patient presented with moderate neck pain.

• 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: 6700034
• MDR Text Key: 79590616
• Report Number: 1030489-2017-01717
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: No
• 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