MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

Model Number MSB_UNK_BMP2_ACS

Device Problem Off-Label Use (1494)

Patient Problems Ossification (1428); Muscular Rigidity (1968); Ambulation Difficulties (2544)

Event Date 01/31/2024

Event Type  Injury  

Event Description

Background: although bone morphogenetic proteins (bmps) are used as an adjunct to promote healing, they may have unintended effects such as heterotopic ossification (ho).The literature is limited regarding the effect of using off-label bmps for femur fractures.Cases presentation:  a 51-year-old african american female presented to our trauma service in 2009 following a high-speed motor vehicle collision (mvc). she suffered injuries including an open right tibia fracture, cervical spine fracture, and a complex left femoral neck and shaft fracture.Reported events: postoperatively, patient developed stiffness in her hip and knee.  patient was found to have extensive heterotopic ossification which nearly bridged the space between the trochanter and the ilium, and extended to her knee.Due to her stiffness, she required two surgeries for ho excision and manipulation.One surgery was for her left hip and the other for her left knee.Patient had painless but limited external and internal rotation of her left hip, and normal intact sensation in her left lower extre mity. however, she continues to have difficulty with ambulation. .

Manufacturer Narrative

H6 - 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.Off-label: the results of adjunctive bone morphogenetic protein for challenging femur fractures; a review of two cases.Authors: julia anne prodoehl, yianni bakaes , michael tucker, frank voss https://doi.Org/10.1016/j.Tcr.2024.100979 trauma case reports volume 50, april 2024, 100979 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19133789
• MDR Text Key: 340493749
• Report Number: 1030489-2024-00296
• Device Sequence Number: 1
• Product Code: NEK
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Device Model Number: MSB_UNK_BMP2_ACS
• Device Catalogue Number: MSB_UNK_BMP2_ACS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• 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
• Patient Age: 51 YR
• Patient Race: Black Or African American