Model Number UNKNOWN |
Device Problems
Break (1069); Fracture (1260); Patient-Device Incompatibility (2682); Device Handling Problem (3265)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical produkte (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
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Event Description
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Internal report number: (b)(4).Date of event is unknown.Tentative summarizing translation from initial importer's narrative: upon insertion of the needle tip hit bone, needle broke, able to remove fragment through introducer.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Exact date of event is unknown.Tentative summarizing translation from initial importer´s narrative: upon insertion of the needle tip hit bone, needle broke, able to remove fragment through introducer.
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Search Alerts/Recalls
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