Catalog Number UNK_SEL |
Device Problems
Overheating of Device (1437); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of the investigation, additional information will be provided in a supplemental report.
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Event Description
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The customer reported the following issue: the materialovigilance declaration has not yet been made by the surgeon, it seems that there was a problem with the screw thread and that there was a spark with a visible flame when the drill was inserted." update: (b)(6) 2022: the procedure could be completed correctly by opening the clavicle ancillary to recover the screw racks of the same size.
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Event Description
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The customer reported the following issue: "the materialovigilance declaration has not yet been made by the surgeon, it seems that there was a problem with the screw thread and that there was a spark with a visible flame when the drill was inserted." update - (b)(6) 2022: the procedure could be completed correctly by opening the clavicle ancillary to recover the screw racks of the same size.
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Manufacturer Narrative
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Correction: please refer to h6 - device code.The reported event could not be confirmed, since the device was not returned and no additional information was available.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.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.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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