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Are lot numbers tracked?

Discussion in 'NuVasive' started by anonymous, Apr 21, 2017 at 11:59 PM.

  1. anonymous

    anonymous Guest

    When they use say Osteocel inside the Coroent cage implanted into a spine does it get recorded anywhere's what the Lot Number was of the Osteocel?

    Is there any FDA regulation requiring recording that data?
  2. anonymous

    anonymous Guest

    Damn, you’re dumb. Are lot numbers tracked? No, shithead. All of the sudden the FDA doesn’t give a shit about traceability, especially on implantable devices. Fucking sales reps.
  3. anonymous

    anonymous Guest

    Read the 157 page complaint filed in United States ex .rel Kevin Ryan vs Nuvasive.

    Stated was illegal to use Osteocell inside the Coroent XL....United States won the case against Nuva....julyish 2015 i think...

    Its why Nuva Investors sued afterwards...sued Nuvasive for their liability.....Investors won against Nuva...

    So....now we are all just waiting for the real big lawsuits....Liability.
  4. anonymous

    anonymous Guest

    NuVasive settled and they were not found "guilty" the former rep you reference who highlighted what he believed was off label promotion and marketing by NuVasive even though he himself, most likely, employed these in sales scenarios to pad his commissions. Rumor is this was KR's second payday with the government. NuVasive moved on to become a $1B company so I believe they paid the fine and moved on quite nicely.

    Yes, all companies that distribute tissue are required to track the lot#/Serial# of tissue to it's final point but that could be the hospital and not necessarily the specific patient. The hospitals track tissue to the specific patient. Important to note that almost all implants used in spine surgery are NOT lot#/Serial # tracked to a patient as they are provided non-sterile. This is not uncommon in Spine, small bone ortho, and CMF
  5. anonymous

    anonymous Guest