This event was originally reported on 3012120772-2022-00019.Fifteen explanted set screws were returned for evaluation on 16 may 2022.Visual inspection noted that six of the set screws had striations across the bottom, indicative of them having come loose.Of these, four presented with unpolished surfaces in the middle of the set screw, indicating they were not completely normalized in the tulip.The remaining nine set screws all showed proper normalization, as evidenced by the polished interior.Additionally, the rods were returned and examined.A significant difference in rod curvature was observed.The root cause is likely related to the incomplete rod normalization on several of the set screws, potentially exacerbated from the inconsistent rod curvatures.Review of labeling: possible adverse events: 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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