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 Ossification (1428); Numbness (2415)

Event Type  Injury  

Event Description

It was reported that the patient underwent a transforaminal lumbar interbody fusion at l4-5 and lumbar instrumented fusion from l3 to l5 using peek cage stuffed with rhbmp-2/acs; then, at the l4- l5 disk space.Sometime post-operatively, the patient developed ectopic bone growth, severe low back pain, numb left leg and dependence on painkillers.

Manufacturer Narrative

(b)(4): neither the device nor applicable imaging study films or patient medical records 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/used 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.

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.

Event Description

It was reported that on: (b)(6) 2009: patient presented with following pre-op diagnosis: lumbar stenosis.For which, patient underwent following procedures: intraoperative fluoroscopy; intraoperative monitoring; decompressive laminectomy, l3 complete, l4 complete and l5 complete; bilateral foraminotomies, l3 bilateral, l4 bilateral, and l5 bilateral; transforaminal lumbar interbody fusion using peek cage stuffed with autologous bone and allograft, at l4-l5 disk space, and bone morphogenic protein was also used; posterior lumbar instrumented pedicle screw fusion at l3 bilateral, l4 bilateral, l5 bilateral using spinal system; fusion with autologous bone harvested from laminectomy as well as autograft; fluoroscopic image guidance.Per op notes, surgeon placed bmp along with autologous bone harvested from the laminectomy along decorticated transverse process of l3 bilateral, l4 bilateral, and l5 bilateral.Patient tolerated the procedure well without any intraoperative complications.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4362803
• MDR Text Key: 17260093
• Report Number: 1030489-2014-04849
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• 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
• Patient Age: 46 YR