MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION SPACER SYSTEM; 4.2MM BONE SCREW, VARIABLE, SELF-DRILLING, 12MM

Model Number	184.052
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The imaging provided shows the 12mm coalition mis anchor at the c5/c6 inferior level backed out.Additional information provided that the set screw positioner was not locked off.It is possible that the blocking set screw was not turned during the initial surgery to lock the construct successfully blocking the implanted anchors; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that there was a revision surgery to replace a coalition bone screw that was loose and caused an anchor to back out 3 days post operatively.
Additional Manufacturer Narrative
The device was not returned for evaluation.The imaging provided shows the 12mm coalition mis anchor at the c5/c6 inferior level backed out.Additional information provided that the set screw positioner was not locked off.It is possible that the blocking set screw was not turned during the initial surgery to lock the construct successfully blocking the implanted anchors; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that there was a revision surgery to replace a coalition bone screw that was loose and caused an anchor to back out 3 days post operatively.

• Brand Name: COALITION SPACER SYSTEM
• Common Device Name: 4.2MM BONE SCREW, VARIABLE, SELF-DRILLING, 12MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 15445453
• Report Number: 3004142400-2022-00138
• Device Sequence Number: 7502377
• Product Code: ODP
• UDI-Device Identifier: 00849044007510
• UDI-Public: 00849044007510
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 184.052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown