The device has been returned for evaluation.We have completed our initial evaluation of the device, however we are waiting for final paperwork on the device to complete the investigation.There has been a total of (b)(4) sold of all lots of this part number since 2012.There has been a total of 3 additional complaints recorded for similar occurrences.Two of which occurred in february and august of 2020 from the same customer.The one additional complaint was recorded in 2015 and was found to be the result of the hospital tampering with the screws.A final report will be submitted once we have all of the paperwork and information necessary.
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