Catalog Number 801-90001 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 03/07/2019 |
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 has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
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Event Description
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On (b)(6) 2019 it was reported to k2m, inc.That a surgery took place in which three screw inserters and a screw removal tool broke at the tip intra-operatively.It is unknown if the patient was revised.(related to 3004774118-2019-00029).
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Manufacturer Narrative
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Upon receipt of further detail it was determined that the revision surgery was planned and not due to a product problem.
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Event Description
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On (b)(6) 2019 it was reported to k2m, inc.That a surgery took place in which three screw inserters and a screw removal tool broke at the tip intra-operatively.It is unknown if the revision was related to a device problem.(related to 3004774118-2019-00029).
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Search Alerts/Recalls
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