Model Number 041251-29A |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6).Currently the data available is poor.As soon as we receive an update a supplemental report will be sent in to the agency.
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Event Description
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Irn# (b)(4).Tentative summarizing translation from initial reporter´s narrative: "during several attempts to place the needle in the spinal space at l2-l3 (after several unsuccessful attempts to place it in l3-l4) the needle broke at 3 cm during the removal procedure of the needle with its introducer.During the procedure i had never csf flow through the needle and we had no paresthesia.At the end the patient moves the legs without any sensitive or physical problems.We called the surgeon to try to surgically remove the tip of the needle with local anesthesia and sedation, after talking to the patient.Finally we succeeded in removing the needle".
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Manufacturer Narrative
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Event took place in italy.Based on clinical assessment and risk assessment this file is considered as closed.
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Event Description
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Irn# (b)(4).Tentative summarizing translation from initial reporter´s narrative: "during several attempts to place the needle in the spinal space at l2-l3 (after several unsuccessful attempts to place it in l3-l4) the needle broke at 3 cm during the removal procedure of the needle with its introducer.During the procedure i had never csf flow through the needle and we had no parestesia.At the end the patient moves the legs without any sensitive or phisical problems.We called the surgeon to try to surgically remove the tip of the needle with local anesthesia and sedation, after talking to the patient.Finally we succeded in removing the needle".
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Search Alerts/Recalls
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