No evaluation possible at this time.The proximal section of the wrench tip has not been returned nor has the lot number been provided.Upon the receipt of additional information and/or the suspect device a follow up report will be submitted.Alphatec solus distal wrench tips are manufactured from (b)(4) (stainless steel) and certified to (b)(4).The tips are used in conjunction with the proximal and distal deployment wrenches in order to deploy the two blades of a solus spacer into the cephalad and caudal vertebral endplates of disc space.The blades of the solus spacer are deployed by the two counter-rotating wrenches (proximal and distal).The solus distal wrench tips are modular, replaceable tips intended for single use.The supplied instructions for use (ins-060) warning# 7 states; do not use with excessively dense vertebrae.In patients where only one of the two vertebrae is excessively dense the safety feature built into the deployment wrench tip will not be effective.
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