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 Inflammation (1932); Pain (1994); Osteolysis (2377)

Event Type  Injury  

Event Description

The information was received from health acre provider via a manufacturing representative regarding a patient for alif spinal therap y.It was reported that patient underwent a alif in (b)(6) 2021 and has persistent pain in her lumbar spine with mri findings suggesting to be consistent with possible bmp inflammatory reaction.Patient is experiencing back pain, radiculitis and osteolytic changes.There was no further information reported.

Manufacturer Narrative

Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.B2: other : inflammation, osteolysis.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.Adverse event: other: inflammation, osteolysis.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

The information was received from health acre provider via a manufacturing representative regarding a patient for alif spinal therapy.It was reported that patient underwent a alif in (b)(6) 2021 and has persistent pain in her lumbar spine with mri findings suggesting to be consistent with possible bmp inflammatory reaction.Patient is experiencing back pain, radiculitis and osteolytic changes.There was no further information reported.

• 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: 13546864
• MDR Text Key: 285739058
• Report Number: 1030489-2022-00155
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• 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 Sex: Female