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Model Number 661440 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2020 |
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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The following event was reported that: "we have just received a material ovigilance concerning the axsos cortical screws.On the radio, the screws were bent, and the threads were turning.Screws concerned: 2 screws bent during placement: 1 cortical 3.5 in 32mm and 1 cortical 3.5 in 40mm: and 2 screws with bad thread: 2 cortical 3.5 in 40mm and 2 locked screws in 28mm.Consequences: the surgeon removed the screws and put in new ones.¿.
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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.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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.However, possible causes of failure could be handling failure, angulated insertion, interference with other screws, etc.If device is returned or any further information is provided, the investigation report will be reassessed.Device disposition is unknown.
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Event Description
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The following event was reported that: "we have just received a materialovigilance concerning the axsos cortical screws.On the radio, the screws were bent, and the threads were turning.Screws concerned: 2 screws bent during placement: 1 cortical 3.5 in 32mm and 1 cortical 3.5 in 40mm: and 2 screws with bad thread: 2 cortical 3.5 in 40mm and 2 locked screws in 28mm.Consequences: the surgeon removed the screws and put in new ones.¿.
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Manufacturer Narrative
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Correction: refer to d9/h3, h6 method, results & conclusion code.The reported event could not be confirmed, since the returned device shows no visible damage and is conforming to specifications.The device inspection revealed the following: overall 5 screws were received.However, none of the received screws of the reported catalog number were found to be defective.No form of deformation or damage could be observed all throughout the screw.The threads were intact, no bend throughout the length could be observed and the hex in the head was also secure.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, since no product deficiency could be observed, the alleged failure cannot be confirmed and therefore the issue is deemed to be user related.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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The following event was reported that: "we have just received a materialovigilance concerning the axsos cortical screws.On the radio, the screws were bent, and the threads were turning screws concerned: 2 screws bent during placement: 1 cortical 3.5 in 32mm and 1 cortical 3.5 in 40mm: and 2 screws with bad thread: 2 cortical 3.5 in 40mm and 2 locked screws in 28mm consequences: the surgeon removed the screws and put in new ones.¿.
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