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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); 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.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
Patient demographics: (b)(6); it was reported that on : (b)(6) 2001 , patient underwent fusion using iliac creast graft and instrumentation at l4-5.On (b)(6) 2002 , patient developed some hardware irritation and underwent removal of the hardware and exploration and right neurolysis.She had significant relief post procedure.On (b)(6)2003, patient visited for chronic pain.She was suggested mri of spine.On (b)(6) 2003, she underwent mri prior to surgery.Impression : postlaminectomy syndrome ; prior severe l4-5 disk degeneration with endplate changes ; chronic right lower extremity neuritic pain.She had pseudoarthrosis of l4-5 which was demonstrated by mri.Per radiological report , recurrent or residual disc protrusion at the l4-5 level with extension into normal bilaterally.Foraminal stenosis is noted on right at this level.7 apr 2003 , patient presented to consult anterior approach surgery scheduled (b)(6) 2003.Impression : pseudoarthrosis at l4-5 ; l4 nerve root irritation by herniated material into foramen ; tobacco abuse ; history of prior c-section ; history of prior appendectomy (b)(6) 2003 , patient visited for preoperative evaluation, anterior posterior fusion at l4-5.Patient complained of back pain , aching and tingling (b)(6) 2003 patient presented with pseudoarthrosis at l4-5.Patient underwent following operative procedure : anterior approach for anterior discectomy of l4-5 , ant.Fusion of l4-5 with lt cages , bmp and platelet gel , pedicle screw.As per medical records, surgeon performed anterior discectomy of l4-5 and anterior fusion with unknown cage and unknown bmp.During the discectomy and fusion the left iliac artery and vein had to be reflected to the right with transient losses of the arterial pulse curve from the left iliac artery as monitored in the left great toe by oximetry.No intraoperative complication noted.During the procedure she was constantly monitored on xrays to check correct position of instrument.She also underwent fluoroscopy procedure.On (b)(6) 2003, patient was discharged with no post op complication.Her hematology test shows good result.On (b)(6) 2003 , patient is seen postoperative for l4-5 anterior posterior fusion.Patient developed leg pain , nausea and vomiting.Her test indicates : wounds are healing well.Pedicle screws and rod are well positioned.Interbody cage well positioned.On (b)(6) 2003, patient visited for follow up.On (b)(6) 2003, patient visited for follow up underwent xray.Status post anterior-posteriorl4-5 fusion.On (b)(6) 2003 , patient visited for follow-up.On (b)(6) 2003 , patient underwent fluoroscopically guided right: s1 transforaminal injection.L5-1 transforaminal epidural steroid injection.Her pre procedure diagnosis : chronic right lower extremity pain ; prior severe l4-5 disk degeneration with spondylolisthesis ; postlaminectomy syndrome.On (b)(6) 2003, patient presented for follow up meeting and underwent x-rays of her lumbar spine.Impression : rule out chronic stenosis at ls-s1 which may be causing some of her radicular symptoms.On (b)(6) 20003 patient visited for follow up of mri scan.There is significant foraminal stenosis right greater than left with subarticular stenosis from ligamentous hypertrophy and foraminal narrowing.On (b)(6) 2003, patient visited for pre-operative history and physical examination.Presented for cbc complete test on (b)(6) 2003.On (b)(6) 2003, patient underwent operative procedure - laminotomy, foraminotomy at l5-s1; release of nerve root and neurectomy l5.Patient was diagnosed with right foraminal stenosis at l5-1.On (b)(6) 2003 , patient underwent basic metabolic profile test.On (b)(6) 2003, patient called complaining of lateral side leg pain right from thigh , calf to ankle.On (b)(6) 2003 , patient visited for follow-up.She complained of pain in the right buttock that she had preoperatively.On (b)(6) 2003, patient presented for removal of screw.Back pain has improved.On (b)(6) 2003, patient visited for follow-up complaining of pain.On (b)(6) 2003, patient presented with low back pain and underwent mri.Impression: operative changes at l4-5 without hardware complication, recurrent central spinal stenosis or exiting nerve root deformity, no esseous trauma , infection or abscess.On (b)(6) 2003 , follow up for ongoing neuritic type right lower extremity pain.On (b)(6) 2003, the patient is here today for followup from her laminotomy after her fusion.Xray impression : ap and lateral lumbar spine films demonstrate the hardware is intact.On (b)(6) 2003, patient visited the (b)(6) for obtaining a dorsal column simulator.On (b)(6) 2010 patient presented for pain management assessment.Mentioned year is suspicious as the other pages mentioned year as 2003.On (b)(6) 2011 , presented for medicine refill.On (b)(6) 2011, presented for medicine refill.On (b)(6) 2011, patient presented for fill out paperwork.On (b)(6) 2011, patient visited for medication review.On (b)(6) 2012, patient visited for medication review.On (b)(6) 2012, patient presented for blood draw.She underwent following procedure: venipuncture (b)(6) 2012, patient presented for follow up check-up and for her blood test report assessment.She has been on disability since (b)(6) 2011.On (b)(6)2012 , patient presented for blood pressure check to assure medication is effective.On (b)(6) 2012, patient presented for general examination.On (b)(6) 2013, patient presented with chronic pain syndrome.She underwent physical and laboratory examinations.On (b)(6) 2014 , patient presented in (b)(6)).
 
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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 Key5045468
MDR Text Key24708280
Report Number1030489-2015-02146
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
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 Received09/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/03/2015
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 Number1
Patient Outcome(s) Other;
Patient Weight73
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