Patient information was not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect open spine clamp.No parts have been received by manufacturer for analysis.No further issues have been reported.(b)(4).
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A medtronic representative reported that, while in a spine procedure, the site's open spine clamp was damaged.The surgeon was preparing to attach the spine clamp to the patient and it the spine clamp could not be tightened or untightened.The surgeon opted to continue the procedure using a different short spine clamp instead.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
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