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

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.

• 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 Key: 6137663
• MDR Text Key: 61193406
• Report Number: 1030489-2016-03314
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/01/2016
• Supplement Dates Manufacturer Received: 11/07/2016
• Supplement Dates FDA Received: 09/27/2017
• 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 Number: 1
• Patient Outcome(s): Other; Required Intervention