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 Cyst(s) (1800); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Literature citation: eli m.Baron , diana m.Mejía , doniel drazin , neel anand;"postoperative cyst associated with bone morphogenetic protein use in posterior and transforaminal lumbar interbody fusion managed conservatively: report of two cases".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.

Event Description

It was reported in an abstract that the patient underwent right-sided l5-s1 transforaminal lumbar interbody fusion in addition to l5-s1 laminectomy and a decompressive laminotomy at l4-l5.Bone morphogenetic protein was used in the intervertebral cage and for a contralateral posterolateral facet fusion.An oblique plif cage was inserted via tlif technique containing 2.1 mg of rhbmp-2.Post-op, several months after surgery, the patient was noted to have new onset buttock pain and right leg pain.Mri of the lumbar spine revealed a hyper-intense fluid collection extending just posterior to the disc space on the right side.On sagittal imaging, this could be seen to be displacing the right s1 nerve root posteriorly.A right l5-s1 transforaminal epidural steroid injection was performed with good relief of symptoms; over several months her leg pain resolved.Follow-up ct scan at one-year post-op displayed a solid interbody fusion and solid fusion of the left l5-s1 facet joint.

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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5892813
• MDR Text Key: 52608644
• Report Number: 1030489-2016-02387
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: 07/26/2016
• Supplement Dates FDA Received: 09/24/2017
• 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
• Patient Age: 29 YR