Catalog Number 111-B55500-SG |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 12/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.
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Event Description
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On 03.21.2017 it was reported to k2m, inc.That a revision surgery took place in which screws were removed.Revision surgery took place (b)(6) 2016.
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.Evaluation in process.
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Event Description
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On 03.21.2017 it was reported to k2m, inc.That a revision surgery took place in which all hardware was removed.Revision surgery took place (b)(6) 2016.
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Search Alerts/Recalls
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