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

Model Number 7510800

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

Patient Problems Inflammation (1932); Neuropathy (1983)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Information received from healthcare provider via manufacturer representative regarding an event happened during post-op of the reported product.The pre-op diagnosis was mentioned as reversal of normal cervical lordosis is noted.Normal coronal alignment.There is visualization below c6.Vertebral body heights are preserved.Congenital stenosis is noted.There is severe sub-axial central stenosis most notable at c4-5 and c5-6 but to a degree c3-t1.Foraminal narrowing noted throughout as well.It was reported that, patient was fine a week after post op.The doctor believes the inflammation was caused by the infuse which lead to the radiculitis.The reported product was used according to ifu and labelling.The product was implanted at postero-lateral and levels implanted were c2-t2.The type of procedure performed pcf.There was an additional treatment or intervention performed but medication/intervention provided to the patient was unknown.No further complications 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: 14975476
• MDR Text Key: 295602128
• Report Number: 1030489-2022-00630
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 7510800
• Device Catalogue Number: 7510800
• Device Lot Number: MFN7815AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Date Device Manufactured: 04/18/2022
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male