Catalog Number UNK_SEL |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384); Positioning Problem (3009)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of investigation, additional information will be provided in a supplemental report.
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Event Description
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As reported: "during surgery, the locking screw did not lock to the plate.The screw was exchanged to a new one, but the situation was not changed.Because the hole of the plate was looked clearly bigger than the other holes and a debris was found, the plate was also exchanged to a new one.The procedure was finished without other problem." no surgical delay or adverse consequences were reported.
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided despite multiple attempts.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
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Event Description
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As reported: "during surgery, the locking screw did not lock to the plate.The screw was exchanged to a new one, but the situation was not changed.Because the hole of the plate was looked clearly bigger than the other holes and a debris was found, the plate was also exchanged to a new one.The procedure was finished without other problem." no surgical delay or adverse consequences were reported.
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Search Alerts/Recalls
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