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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CAPSTONE VERTEBRAL BODY SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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MEDTRONIC SOFAMOR DANEK CAPSTONE VERTEBRAL BODY SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Neuropathy (1983); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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.(b)(4).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) 2007: patient presented with following pre-op diagnoses: status post l2-l5 lumbar fusion; diskogenic low back pain l4-s1.For which, patient underwent following procedures: l5-s1 posterior spinal fusion; l5-s1 bilateral lateral recess decompression; l5-s1 posterior lumbar interbody fusion; segmental instrumentation using titanium system; implantation capstone cages x2; local bone graft, allograft bone graft, rhbmp-2/acs; running and triggered emgs; intraoperative ct scan evaluation; intraoperative fluoro navigation.Per op notes, a trial was performed with a 25 x 12 mm in height capsule and cage was implanted into the disk space.Intraoperative fluoroscopy was employed and showed the case to be in satisfactory position.Next, the actual cage was filled with allograft bone graft.Rhbmp2 was placed anterior to the cage and the cage was impacted at the l5-s1 level.An identical procedure was performed on the right side and bilateral cage implantation was obtained.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2007: patient presented with following pre-op diagnoses: status post l5-s1 posterior lumbar interbody fusion; interbody cage of migration causing bilateral radiculopathy.For which, patient underwent following procedures: anterior lumbar decompressive diskectomy; removal of capstone cages x2; l5-s1 anterior interbody fusion; implantation precision bone implant times one; implantation infused rhbmp-2/acs; application titanium plate.Per op notes, the implants were identified.These were noted to be grossly loose and eroded into the superior endplate of l5-5.These were hooked with a nerve hook and then gently removed from the disk space.It was agreed that implanting the bone implant flush with the anterior cortex of l5-s1 would provide the greatest support at this level.Good resistance to collapse was evident due to the posterior instrumentation.The implant was filled with rhbmp-2/ acs and then placed into position.The implant was slightly impacted into position and good the anterior support was felt to be obtained.Patient tolerated the procedure well without any intraoperative complications.
 
Manufacturer Narrative
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.
 
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Brand Name
CAPSTONE VERTEBRAL BODY SPACER
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
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 Key6137663
MDR Text Key61193406
Report Number1030489-2016-03314
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 11/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/07/2016
Initial Date FDA Received12/01/2016
Supplement Dates Manufacturer Received11/07/2016
Supplement Dates FDA Received09/27/2017
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 Number1
Patient Outcome(s) Other; Required Intervention;
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