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

Device Problem Leak/Splash (1354)

Patient Problem Abdominal Pain (1685)

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via medwatch (mw5082004) that on (b)(6) 2015, the patient underwent anterio-posterior bilateral discectomy and fusion at l4-l5.During this invasive surgery, rhbmp-2/acs was also implanted.During the surgery, the peek cage broke and was left in the patient.In 2018, the patient underwent an emergency revision at l4-l5.The reason for the revision surgery was not mentioned.3 weeks post this revision surgery, the patient returned with low left abdominal quadrant pain.Ultrasound confirmed a mass/fluid.Biopsy was inconclusive.Patient believed that rhbmp-2/acs leaked from the broken cage and spread through the body.Patient underwent tests for cancer, hepatitis, autoimmune but all these tests were ruled out.Patient is currently attending anesthesiology, hematology, neurosurgery, rheumatology.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8291708
• MDR Text Key: 134563826
• Report Number: 1030489-2019-00093
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2019

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
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/31/2019
• 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): Required Intervention