There have been no products, lot numbers or other identifiers provided for evaluation as of the time of this report.The user states that there have been 3 instances of the plate coming loose.Based on the radiograghs provided by the reporter, the issue has been confirmed.The investigation for this case is ongoing.Review of labeling: possible adverse events.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
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