MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SECURE-C; SECURE®-C ENDPLATE & CORE ASSEMBLY, 11X12, 6MM, 0°

Model Number	714.176S
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.The implant was in good condition with minimal signs of wear and tear.The bearing surfaces on the core and endplates were in good condition with no signs of deformation.There was minor deformation around the edges of the core which is consistent with using general surgical instruments to remove the core from the disc space.It was reported that the surgeon cut the keels using the broach followed by the chisel.Following the keel cut step, the surgeon used the nerve hook to clear out any remaining bone from the keel cuts.The implant was loaded onto the implant holder, while impacting the implant into the disc space it was noticed that superior endplate was not as posterior as the inferior endplate.The implant holder was disconnected and the single endplate positioner was utilized in an attempt to move the superior endplate more posterior.There was not much movement on the first and second taps, but when the surgeon hit the positioner a third time more aggressively, the superior endplate moved diagonally posteriorly and landed on the dura.The surgeon pulled the implant out with a rounger and performed an acdf with hedron c and xtend plate with screws.There were no adverse effects to the patient.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a secure-c implant needed to be removed after being dislodged intraoperatively.

• Brand Name: SECURE-C
• Common Device Name: SECURE®-C ENDPLATE & CORE ASSEMBLY, 11X12, 6MM, 0°
• 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: 20321907
• Report Number: 3004142400-2024-00237
• Device Sequence Number: 20834547
• Product Code: MJO
• UDI-Device Identifier: 00889095179088
• UDI-Public: 00889095179088
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/26/2024

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: 714.176S
• Device Lot Number: GBB268CD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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