MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. GRAFTON®AND GRAFTON PLUS®DEMINERALIZED BONE MATRIX (DBM); FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	T44150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Pt having a multi-level spinal fusion that required use of bone graft material specifically orthoblend which is a medtronic product that comes in 5 and 10 cc amounts.For this case dr requested 30 cc of orthoblend.The boxes & inside packages were shown to the scrub tech prior to opening and all product descriptions, amounts & expiration dates were verified between the circulator & the scrub.The orthoblend was passed sterily to the field in its silver packages x3 (contents not visible) and the scrub tech continued their set up while the patient was positioned.Several minutes later when the scrub opened the silver orthoblend packages it was discovered that 1 of the 3 packages contained allograft that was discolored (brownish) as compared to the other 2 which were normal (beige) in color.The surgical team decided to discard the brownish colored bone graft ( orthoblend) and open a new box of 10 cc orthoblend.All bone graft labels are required to be placed on the implant sheet.At this time it was impossible to state which box had the discolored bone graft because all 3 were opened at the same time.

• Brand Name: GRAFTON®AND GRAFTON PLUS®DEMINERALIZED BONE MATRIX (DBM)
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 24257577
• Report Number: 24257577
• Device Sequence Number: 8326822
• Product Code: MQV
• UDI-Device Identifier: 00643169122932
• UDI-Public: (01)00643169122932
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/21/2026
• Report Date (Section F): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T44150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Date Report Sent to FDA: 01/21/2026