MAUDE Adverse Event Report: MEDTRONIC SPINALGRAFT GRAFTON ORTHOBLEND SYR DBM GEL 5CC FLWBL GRAFTON; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number T44145

Patient Problem Paralysis (1997)

Event Date 01/12/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, during an anterior cervical discectomy and fusion acdf c4/5 possible removal of the existing zimmer cervical plate due to adjacent level disease, it was previously implanted at cr-7, the surgeon was using acis set to implant an acis pro ti cervical graft.The surgeon either has to use zero p at c4/5 or remove the plate to use acis and skyline.He ended up removing the plate and used acis and a skyline single-level plate.He inserted the implant and upon removal of the inserter realized it was too far.The patient partially lost motors from the chest down.(no equipment broke or malfunctioned) a variety of instruments were used to remove the spacer which he was able to do.A new graft was placed, the plate was removed but not replaced and implanted with screws.Once the case was completed neuro monitoring showed that one side of her body was getting some motor response while the other side was not.There was a surgical delay when the graft had to be removed.The patient was taken to the icu and had not progressed very well.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref reports: mw5120548, mw5120549, mw5120550, mw5120551, mw5120552, mw5120553.

• Brand Name: GRAFTON ORTHOBLEND SYR DBM GEL 5CC FLWBL GRAFTON
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): MEDTRONIC SPINALGRAFT
• MDR Report Key: 17458313
• MDR Text Key: 320519140
• Report Number: MW5120547
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/02/2023

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?: No
• Device Model Number: T44145
• Device Lot Number: A49974078
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Patient Sequence Number: 1
• Treatment: GRFT BONE SUB SM 1ML FRMBL LATXFREE VIVIGEN BL (LEFT FOOT): MFR: LIFENET, PRODUCT# BL-1600-001, LOT# 21130578044; GRFT BONE SUB SM 1ML FRMBL LATXFREE VIVIGEN BL (RIGHT FOOT): MFR: LIFENET, PRODUCT# BL-1600-001, LOT# 21130578044; ROD SPNL 40 DIA3.5 LATXFREE INFINITY OCT: MFR-MEDTRONIC SPINAL & BIOLOGICS, PRODUCT# 3603740, LOT UNK; SCR SPNL 10 DIA3.5 LATXFREE INFINITY OCT: MFR-MEDTRONIC SPINAL & BIOLOGICS, PRODUCT# G3603510, LOT # UNK; SCR SPNL 12 DIA3.5 LATXFREE INFINITY OCT: MFR: MEDTRONIC SPINAL & BIOLOGICS, PRODUCT# 3603512, LOT # UNK; WIRE FXTN 0.062X51IN #316 C-WIRE, MFR: LINVATEC CORP, PRODUCT # 00505004900, LOT# 488949