MAUDE Adverse Event Report: MEDTRONIC SOFAMO DANEK USA, INC. INFUSE BONE GRAFT XX SMALL KIT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number	7510050
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Major life changing event started after 2 stage spinal fusion ((b)(6) 2017).(b)(6) 2019: discover medtronic titanium pedicle screw at l4, screw head broke off and screw head lodged into muscle.Two different neurosurgeons call it pseudarthrosis or failed back surgery.(b)(6) 2022: discover on my own fda recall ref 7510050.What is the reason for why no one would contact me about the recall? (b)(6) 2022: revision surgery rescheduled until ct scan completed.(ct scan completed on (b)(6) 2022).(b)(6) 2022: office visit with dr (b)(6) to review all images, develope surgery plan, and schedule revision surgery.Please see other relevant history for detailed explanation.

• Brand Name: INFUSE BONE GRAFT XX SMALL KIT
• Common Device Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMO DANEK USA, INC.; 4340 swinnea road; memphis TN 38118
• MDR Report Key: 15537063
• Report Number: MW5112396
• Device Sequence Number: 20187046
• Product Code: NEK
• UDI-Device Identifier: 00613994239525
• UDI-Public: 00613994239525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 7510050
• Device Catalogue Number: M705174B004
• Device Lot Number: M111806AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC FUSE CAGE TITANIUM 10MM X 24MM X 4 DEG, EXP: 10/21/2024; MEDTRONIC FUSE SPINAL SYSTEM CAGE 11MM X 24MM X 8 DEG: REF 2881124, LOT: 0469869W, EXP: 4/27/2024; SUPPLIES & CHARGES: PAK NEEDLE 2 TROCAR REF: 8670015
• Outcome Attributed to Adverse Event: Required Intervention; Other; Disability
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White