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 Pain (1994); Ambulation Difficulties (2544)

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 that post-op, the patient suffered major pain, inability to stand or walk for any period of time.Patient stated that she could not stand for long time, was in constant pain.She was permanently disabled and now had been diagnosed with fibrous dysplasia.There was overgrowth of bone due to the use of bone morphogenic protein (bmp) used in her right femur.X-rays which showed that the bmp had taken over than 50% of the femur.She was being scheduled for surgery again to remove a cyst in her leg due to overgrowth of bone in the future.The patient was a minor when initial surgery took place in 2013.She had fractured her femur and had surgery but she developed a blood cyst- a revision surgery was then done where bmp bone graft was used.She had not had any additional surgery since that time, but now had been diagnosed with fibro dysplasia and alleges her surgeon stated bmp caused issues and she has bone overgrowing in femur.

• 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: 8784236
• MDR Text Key: 150814204
• Report Number: 1030489-2019-00754
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/12/2019
• 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): Other
• Patient Age: 16 YR