MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION MIS; COALITION MIS ANCHOR, 12MM

Model Number	1136.2012
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation as it was discarded by the hospital.Additional information provided after the first anchor was deployed, the spacer was deemed to be in an appropriate position.The second anchor was deployed and it was discovered that the spacer had moved roughly 5mm posteriorly and the patient had lost motor function.The surgeon decided to perform a corpectomy to remove the implants.It is possible that the causes could be related to surgical technique, implant sizing, or another unknown issue; however, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that 2 coalition mis anchors were advanced too far causing the patient to lose motors.The anchors were unable to be retrieved with the removal tool, resulting in the surgeon performing a corpectomy to remove the cage and screws.

• Brand Name: COALITION MIS
• Common Device Name: COALITION MIS ANCHOR, 12MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11226786
• Report Number: 3004142400-2021-00011
• Device Sequence Number: 19762503
• Product Code: OVE
• UDI-Device Identifier: 00889095358940
• UDI-Public: 00889095358940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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: Health Professional
• Device Model Number: 1136.2012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR