MAUDE Adverse Event Report: SOFAMOR DANEK- SOFA / MEDTRONIC SOFAMOR DANEK USA, INC. INFUSE BONE GRAFT SMALL; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number 7510200

Patient Problems Abscess (1690); Bacterial Infection (1735); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Date 08/03/2023

Event Type  Injury  

Event Description

Had spinal surgery to implant a spacer on (b)(6) 2023 to relieve pressure between l3-4.Two devices implanted in spine lumbar.Post op bacterial infection diagnosed upon admission to hospital on (b)(6) 2023.Experienced severe pain and spasms since surgery and mri conducted on (b)(6) 2023 and read on (b)(6) 2023 found "status post interbody spacer at l3-4 with edema in the disc space, adjacent vertebral bodies, ventral epidural space and psoas muscle with apparent left psoas abscess.Findings are concerning for discitis osteomyelitis." hospitalized from (b)(6) 2023.Treated with broad spectrum iv antibiotics and released with picc line installed to continue iv antibiotics for 6-8 weeks.Due to lab error the bacteria was not speciated and there was no original specimen left to do so from before antibiotics were administered in the hospital.Two devices implanted: 1.Infuse bone graft small manufacturer: sofamor danek sofa; model number: 7510200; lot number: mgp7850aaa 2.Cage 10x18x55-10deg- manufacturer: nuvasive - nuva; model number: 1181055p2 implanted by: dr.(b)(6) neurosurgeon.(b)(6) implanted at: (b)(6) hospital (b)(6)."status post interbody spacer at l3-4 with edema in the disc space, adjacent vertebral bodies, ventral epidural space and psoas muscle with apparent left psoas abscess.Findings are concerning for discitis osteomyelitis." ref report: mw5144932.

• Brand Name: INFUSE BONE GRAFT SMALL
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): SOFAMOR DANEK- SOFA / MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 17622954
• MDR Text Key: 322081215
• Report Number: MW5144931
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 7510200
• Device Lot Number: MGP7850AAA
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian