Product information not available.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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A new linkedin connection messaged me on (b)(6) 2017 stating he knew two people that worked for depuy spine.He then stated that he "just had two surgeries last year to remove the hardware from my spine.Muscles rubbing over the hardware was causing inflammation and chronic pain.Doing much better now! the hardware was all j&j, viper and expedium.I kept it all, thinking of making something with it." (b)(6) on (b)(6) 2017 email from patient: after receiving fusions in upper levels, it was determined by 2nd opinion that my chronic pain was attributed to muscles rubbing over the hardware causing inflammation.I had two surgeries to remove the hardware from t3-s1 in 2016 ((b)(6)).The chronic pain, just from walking, went away.I do still have constant/chronic pain depending on activity level, but reduced.
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