Catalog Number 2001-15525 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 03/30/2017 |
Event Type
malfunction
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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.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.User disposed.
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Event Description
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On 04.03.2017 it was reported to k2m, inc.That a surgery took place in which the third screw would not lock into a cage and the cage was left implanted with two screws.Surgery took place (b)(6) 2017.
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.It was reported that the patient had poor bone quality and that the surgeon was not concerned about the integrity of the overall construct.Since the implants remain in the patient, no examination could be completed and therefore a definitive root cause could not be determined.(related to 3004774118-2017-00052 and 3004774118-2017-00076).User disposed.
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Event Description
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On 04.03.2017 it was reported to k2m, inc.That a surgery took place in which the third screw would not lock into a cage and the cage was left implanted with two screws.Surgery took place (b)(6) 2017.
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Search Alerts/Recalls
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