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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Immunodeficiency (2156); Cancer (3262)

Event Date 12/01/2013

Event Type  Injury  

Manufacturer Narrative

Outcomes attributed to adverse event: cancer although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.If information is provided in the future, a supplemental report will be issued.

Event Description

The information was received from consumer via a manufacturing representative regarding a patient with infuse part for spinal therapy.It was reported that patient had infuse implanted in her neck in 2013.As a result, she has tumors in multiple sites of her body, for example lungs, liver, etc.She is having trouble swallowing because the bone is growing into her esophagus.She is immune deficient.Her blood test results show she has auto-antibodies to all of her organs.She has graft vs host disease.She did a ¿23 and me¿ dna test and it shows she is not 50/50 part of her mother and father, but from 50 different people because she was told infuse uses bone marrow from many different donors.She wants someone to contact her b/c she is trying to save her life and potentially other people.Wants to know how to turn off the growth.There was no further complication reported as result of this event.

• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11981302
• MDR Text Key: 255624832
• Report Number: 1030489-2021-00777
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 05/14/2021
• 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