The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: loosening, migration and/or fracture of the implants can occur due to loss of fixation, trauma, misalignment, bone resorption, and/or excessive activity.
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of device history records indicated that the devices were manufactured to specifications.As the returned product was able to assemble correctly when tested and no significant damage could be noted on the returned product, the alleged complaint could not be reproduced.The most likely cause of the screws at the collar becoming loose cannot be conclusively determined.
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