MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. GRAFTON PLUS DBM 10 ML; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number T45010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Muscle Weakness (1967); Nervous System Injury (2689)

Event Date 07/30/2022

Event Type  Injury  

Event Description

The patient underwent posterior cervical decompression and fusion for resection of a tumor.Medtronic grafton plus dbm (a standard bone graft used in spine surgery) was used as allograft to supplement the local autograft.It was applied to the facet joints in standard fashion.The spinal cord was completely free of compression at wound closure.A surgical drain was placed and removed postop day 2 after output was satisfactorily low.The patient was neurologically stable until postop day 5, when she when acutely decompensated from full 5/5 strength in all extremities to 0/5 strength in the distal upper extremities and entire lower extremities.Mri demonstrated a large fluid collection in the surgical bed causing cord compression, and the patient was emergently returned to the operating room.The fluid collection had a thin, off-white appearance with pieces of the medtronic grafton plus dbm mixed in with it.There was no hematoma, pus, or csf (more typical causes of postoperative collections).We suspect that the patient had an allergic reaction to one of the processing agents in bone graft (e.G.Surfactant or antibiotics), a fluid collection resulted from the inflammatory response.Diagnosis for use: bone graft for spine surgery.

• Brand Name: GRAFTON PLUS DBM 10 ML
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 15147850
• MDR Text Key: 297155758
• Report Number: MW5111225
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 00643169123038
• UDI-Public: 00643169123038
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: T45010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White