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 Syncope (1610); Chest Pain (1776); Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Depression (2361); Sore Throat (2396); Numbness (2415); Palpitations (2467); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Procedure: anterior lumbar interbody fusion levels implanted: l4-l5 it was reported that, the patient underwent spine fusion surgery on the lumbar region at levels l4-l5.The patient was implanted with rhbmp-2 collagen sponge.Post-op, the patient complained of progressively worsening low back with radiculopathy and swelling in her lower extremities, significant muscle spasms in her low back and buttocks, weakness in her left leg and left foot drop.Patient still continues to experience chronic low back pain with radiculopathy into her hips and left lower extremity.She has extreme weakness in her left leg and suffers from left foot drop, which requires use of an brace when ambulating.She experiences difficulty standing and walking.Patient injuries prevent him from practicing daily life activities and reportedly the patient has suffered serious and permanent injuries.

Manufacturer Narrative

(b)(4).Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.

Manufacturer Narrative

D.

Event Description

It was reported that on: (b)(6) 2009 patient underwent the following surgery: anterior retroperitoneal exposure l4-5 to treat the following pre-op diagnosis: l4-5 disk disease.(b)(6) 2009 patient underwent the following surgery: l4-5 anterior lumbar interbody fusion, application of anterior lumbar interbody device (synthes peek implant 8 degrees x 13.5 mm x 26 mm), application of anterior lumbar instrumentation l4-5 (synthes synfix titanium plate with four 20 mm screws), l4-5 anterior lumbar discectomy, left anterior iliac crest bone graft harvest.Per operative notes: a 26 mm screw was placed into the l4-5 disc space and ap and lateral fluoroscopic images confirmed the correct operative level as well as the midline.The midline was marked and the screw was removedone morphogenic protein was then mixed away from the operative field and allowed to mature for 15 mins.At this point, the synthes synfix device was packed with autologous bone graft and the bmp sponges and then impacted into place between l4 and 5 disc spaces reassessed approximately 1 to 2 mm and was found to have an excellent secure fit.The synthes synfix titanium plate was then secured to the anterior lumbar spine with a standard jig and four 20 mm locking screws.All the screws were tightened nicely into the plate and found to have an excellent fit.The patient was transferred from the operating table to the stretcher at which point she was extubated by the anesthesia service without complication (b)(6) 2009, the patient presented with complaint of back pain and underwent lumbar spine x-ray post lumbar interbody fusion.(b)(6) 2009, the patient presented with left leg extremity weakness.(b)(6) 2009, the patient underwent lumbar spine x-ray post lumbar interbody fusion.(b)(6) 2009, the patient presented with complaint of sore throat/cold.Assessment : sinusitis (b)(6) 2009, the patient presented for office visit.(b)(6) 2009, the patient presented for post-op follow up complaining absence of sensation from the knee.(b)(6) 2009 patient presented due to "rx emg lle dx l foot weakness" (b)(6) 2009 patient presented due to drop foot.(b)(6) 2010, the patient presented with lower left extremity foot weakness, back pain and underwent nerve conduction study.Conclusion: technically difficult study due to pain and poor activation of muscles.There is no clear evidence of left lumbar radiculopathy or left peroneal neuropathy on this study.(b)(6) 2010 patient presented due to "s/p l4-5 anterior lumbar fusion; l foot weaknesss" , (b)(6) 2010, the patient presented for follow up visit for lower extremity weakness and underwent physical therapy session.(b)(6) 2010 patient called office; she had more feeling in her left leg.(b)(6) 2010, the patient presented for follow-up.Impression: near one year post l4-5 anterior lumbar interbody fusion with left lower extremity weakness (b)(6) 2010, the patient presented for office visit for exercise and physical therapy.(b)(6) 2010, the patient presented with diagnosis of s/p l4-5 fusion with residual left leg weakness.(b)(6) 2010, the patient presented for post of follow up and underwent x-ray for lumbar spine.Impression: continued improvement in left lower extremity weakness.Right sided sacroillitis.(b)(6) 2010, the patient presented for evaluation of her back pain, buttock numbness, nausea, headache.The patient had x ray of pelvis.Findings: the hip joint spaces were well maintained.No fractures were identified.X ray of lumbar spine was also performed.Findings: well-maintained disc spaces, vertebral bodies were well aligned.No fracture was identified.(b)(6) 2010 patient called office due to pain.(b)(6) 2010 patient called office.(b)(6) 2010, the patient presented for physical therapy session.(b)(6) 2010, the patient presented with dog bite on her right hand.(b)(6) 2010, the patient presented for follow up of her hand.The patient got discharged from laceration care followed by discharge instruction/ notes.(b)(6) 2010, the patient presented for follow-up of her dog bite.(b)(6) 2010, the patient presented for suture removal.(b)(6) 2010 patient called office.(b)(6) 2010, the patient presented for reexamination.(b)(6) 2011, the patient presented for pain control assessment.(b)(6) 2011, the patient presented to discuss her back pain condition.(b)(6) 2011, the patient presented with complaint of chest pain.(b)(6) 2011, the patient presented with complaint of leg pain.(b)(6) 2011, the patient presented with headache and syncope, underwent ct scan for head.Impression: normal.(b)(6) 2012, the patient presented with complaint of swollen toes.(b)(6) 2012, the patient presented with complaint of left leg pain, persistent foot drop, stress /anxiety, insomnia, breast tenderness.(b)(6) 2013, the patient presented with complaint of tender left sided lymph node and facial acne.(b)(6) 2013, the patient presented for follow up.Assessment: palpitation with muscle twitching episode.(b)(6) 2013, the patient presented for follow up appointment.Assessment: depression with anxiety and panic, attention deficit hyper activity disorder [adhd].(b)(6) 2014, the patient presented due to elbow injury occurred two days ago with occasional numbness in the elbow , (b)(6).The patient also requested medicine refill for chronic back pain and joint pain.(b)(6) 2014, the patient presented for follow up and medicine refill.Assessment: depression, adhd, anxiety, chronic pain.(b)(6) 2014, the patient presented for controlled substance assessment.Assessment: chronic lumbar pain.

Event Description

It was reported that on, (b)(6) 2009 : the patient underwent physical examination.Impression: l4-5 degenerative disc disease with loss of disc signal intensity and height.Hip and lower extremity pain un-responsive to conservative medications.On (b)(6) 2009: the patient presented for custom molded ankle-foot arthosis (afo) for a left foot drop.On (b)(6) 2009, the patient presented for post-op follow up complaining absence of sensation from the knee.The patient underwent lumbar spine three views.Findings:l4-l5 fusion appears unremarkable.The other disc spaces are normal and there is no unusual bone lesion and mal-alignment.On (b)(6) 2010: the patient presented with a chief complaint of low back pain of a chronic nature.On (b)(6) 2010: patient was admitted to the hospital for tylenol and adderall overdose.On (b)(6) 2013, the patient presented for follow up.Assessment: palpitation with muscle twitching episode.

Event Description

It was reported that on: (b)(6) 2009: patient underwent x-ray of lumbar spine.Findings: bony alignment was normal.There was an intervertebral spacing device and cortical screws at l4/5.There was no fracture evident.On (b)(6) 2009 the patient underwent x ray of the lumbar spine.Findings: post discectomy and graft placement and lumbar fusion at l4-5.Normal alignment.No evidence of non-union.The other discs spaces are well preserved.Facet joints and sacroiliac joints seem unremarkable.On (b)(6) 2013, the patient presented with diagnosis of fatigue.On (b)(6) 2013, the patient presented for sleep study.Polysomnography was conducted.On (b)(6) 2014, the patient presented for controlled substance assessment.Assessment: chronic lumbar pain.On (b)(6) 2015,the patient presented with left sided pain.Assessment : chest pain, musculoskeletal ; anxiety , depression.

Event Description

It was reported that on (b)(6) 2009: patient presented with swelling in left lower extremity and weakness in her entire left extremity.Patient underwent a physical examination.Impressions: one week status post l4-5 anterior lumbar interbody fusion with left lower extremity weakness.On (b)(6) 2009: the patient presented for custom molded ankle-foot arthrosis (afo) for a left foot drop.(b)(6) 2009: patient presented for office visit 6 weeks status post l4-5 anterior lumbar interbody fusion.Radiographs: ap and lateral radiographs were taken which demonstrate hardware in good position.There is early evidence of bridging ,bone across the interbody space.On (b)(6) 2009, the patient underwent lumbar spine x-ray post lumbar interbody fusion.Impression: l4-5 disc well maintained.Normal alignment.No usual bony lesion or evidence of hardware failure.Facet joints and sacroiliac joints seen unremarkable.On (b)(6) 2009: patient presented with a diagnosis of status post l4-5 fusion, left lower extremity weakness.On (b)(6) 2009: patient presented for office visit 3 months status post l4-5 anterior lumbar interbody fusion.Patient continues to have left lower extremity weakness which she describes has actually gotten worse since last visit and attributes to brace itself.Radiographs: ap and lateral radiographs were taken which demonstrate ,hardware in good position.There is a column of bridging bone across the interbody space on the lateral view.There is no change in position of the instrumentation.On (b)(6) 2009, the patient presented for office visit.Physical examination: patient continues with diffuse left lower extremity weak ness from the hip flexor, which actually appears to be 'slightly weaker than the last visit.She does have decreased sensation in all dermatomes from the knee distally, however, fairly normal sensation proximally.Impression: five months status post l4-5 anterior lumbar interbody fusion, diffuse left lower extremity weakness and decreased sensation.On (b)(6) 2009, the patient presented for post-op follow up complaining absence of sensation from the knee distally on the medial, lateral and posterior aspects of the entire leg (b)(6) 2009, (b)(6) 2010, the patient presented with diagnosis of s/p l4-5 fusion with residual left leg weakness.On (b)(6) 2010: patient presented for office visit.On (b)(6) 2010, the patient presented for reexamination.Assessments: mood disorder.Severe anxiety.Suicide attempt.

Manufacturer Narrative

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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4861001
• MDR Text Key: 5849615
• Report Number: 1030489-2015-01259
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Catalogue Number: 7510100
• Device Lot Number: M110814AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2008
• 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: 62