Catalog Number UNK_SEL |
Device Problems
Material Erosion (1214); Difficult to Remove (1528)
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Patient Problems
Injury (2348); Device Embedded In Tissue or Plaque (3165)
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Event Date 12/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
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Event Description
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As reported: "axos dmt extraction surgery.Two locking screw heads slipped.The doctor tried to scrape with a carbide drill.Eventually, it was closed with the plate and two screws left.The operation is over and scheduled to be re-ope on december 17th." it was further clarified that the screws had stripped and the extraction occurred on december 17th.
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Event Description
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As reported: "axos dmt extraction surgery.Two locking screw heads slipped.The doctor tried to scrape with a carbide drill.Eventually, it was closed with the plate and two screws left.The operation is over and scheduled to be re-ope on (b)(6)." it was further clarified that the screws had stripped and the extraction occurred on (b)(6).
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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 evidences were provided.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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