The implant was not made available for review as it remains in-site; however review of the x-ray provided confirms the s1 set screw disassociated from the construct.
The patient is asymptomatic and the surgeon will continue to monitor for any indication prompting surgical intervention.
Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
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