Model Number VPT02A |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Similar device 510k: k070527; k063248.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from hcp via manufacturing representative regarding patient with indication of osteoporosis for spinal therapy.The event occurred intra-op.Patient demographics: (b)(6).It was reported that the curve was inside vertebral body when the snap was heard by doctor.The bone was super soft without sclerotic pockets.The doctor wasn't twisting it around or doing anything that would cause stress on the metal.He was advancing it through very soft bone.After the snap was heard, he pulled it out and the curve was broken at the tip holding together by a thread and came apart as soon as it was out of the cannula.Hcp was demanding a full report to be provided to him.Product will be returned back.No patient symptoms were reported.No further complications reported.
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Event Description
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Information was received from hcp via manufacturing representative regarding patient with indication of osteoporosis for spinal therapy.The event occurred intra-op.It was reported that the curve was inside vertebral body when the snap was heard by doctor.The bone was super soft without sclerotic pockets.The doctor wasn't twisting it around or doing anything that would cause stress on the metal.He was advancing it through very soft bone.After the snap was heard, he pulled it out and the curve was broken at the tip holding together by a thread and came apart as soon as it was out of the cannula.Hcp was demanding a full report to be provided to him.Product will be returned back.No patient symptoms were reported.No further complications reported.Procedure planned was kyphoplasty.
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Manufacturer Narrative
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H3: product analysis #703848431:part # vpt02a lot # 219060536 visual and optical inspection revealed a portion of the tip of the curved needle has broken off.The fracture edges are slightly angled and rigid.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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