Catalog Number UNK_TNE |
Device Problems
Shipping Damage or Problem (1570); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was missing at the time of surgery.
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Event Description
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A revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.This pi is about a mistake in ordering the instruments additional information: the revision surgery took finally place on (b)(6) 2021.
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Event Description
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A revision of the surgery performed about a year ago was scheduled due to confirmed postoperative screw fracture.However, before the revision, a mistake in ordering the instruments was discovered and the surgery was postponed.The patient was under general anesthesia.This pi is about a mistake in ordering the instruments.**additional information: the revision surgery took finally place on (b)(6) 2021.
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Manufacturer Narrative
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Please note correction to h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Through the available information, the alleged issue is identified to be most likely a user related event wherein incorrect instruments were ordered by the user.However, more information is required to thoroughly investigate and 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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