MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO S2AI STABILIZATION SYSTEM; CREO PREFERRED ANGLE SCREW, 8.5X80MM, CANNULATED, COCR HEAD, TI SHANK

Model Number	7218.8880
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A creo preferred angle screw, a 5.5x95mm curved rod, and a threaded locking cap were received for evaluation.Observations show the screw shank to have fractured just below the screw head.Other markings on the screw head and screw are consistent with normal use and the spherical portion of the screw shank remains locked inside of the screw head body.Several large markings observed on the proximal end of the broken shank are consistent with markings from instrumentation used to remove hardware.All other hardware received shows wear and markings consistent with normal use.An exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that there was a revisions surgery due to a creo s2ai screw that had broken post operatively.

• Brand Name: CREO S2AI STABILIZATION SYSTEM
• Common Device Name: CREO PREFERRED ANGLE SCREW, 8.5X80MM, CANNULATED, COCR HEAD, TI SHANK
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12569352
• Report Number: 3004142400-2021-00185
• Device Sequence Number: 11116548
• Product Code: NKB
• UDI-Device Identifier: 00193982069162
• UDI-Public: 00193982069162
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D354574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 09/28/2021

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: 7218.8880
• Device Lot Number: BAY204HB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• 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: 46 YR