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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Fatigue (1849); Pain (1994); Swelling (2091); Joint Disorder (2373)

Event Type  Injury  

Event Description

It was reported that in (b)(6) 2010, the patient sustained a right humerus fracture and she underwent a fusion surgery with a plate.Several month later, the bone broke again and the patient had another fusion surgery with plate and screws.In (b)(6) 2012, bone broke again and she underwent fusion surgery using rhbmp-2/acs.Post-op, the patient has developed joint deterioration, swelling, pain, eye problems, a lesion on her skin, and extreme fatigue.Patient is undergoing many tests to determine the cause of her symptoms, but no answer has been found.Her blood work was negative for lupus and rheumatoid arthritis.The patient has seen a lung specialist, a dermatologist, an eye specialist, and an orthopedic surgeon.The orthopedic surgeon reportedly said that "something is attacking her joints." an mri reportedly indicated that "something is attacking her joints" and the physician thinks there is an autoimmune problem.No additional information was provided.

Manufacturer Narrative

(b)(4).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.Products from multiple manufacturers were implanted 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.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOIN
• 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: 4665625
• MDR Text Key: 5623271
• Report Number: 1030489-2015-00735
• Device Sequence Number: 1
• Product Code: MPW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• 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: 03/09/2015
• 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