Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 05/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Two lots were returned that were not reported, therefore initial reports 3003853072-2016-00103 and 3003853072-2016-00104 were submitted.Reference supplemental reports 3003853072-2016-00060-1 through 3003853072-2016-00064-1.
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Event Description
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Since (b)(6) 2015, the patient had begun experiencing increasing low back pain.On (b)(6) 2016, it is noted in an office note that there is evidence of a broken screw.No specific occurrences (e.G.Trauma, non-compliance) are related to this occurring.The patient's bone quality and current status/condition was not indicated.It is reported fusion did not occur.No x-rays or surgical report are available at this time.Indication of the initial surgery degenerative disc at lumbar 4-5, 5-sacral 1 with spondylolisthesis.Description of the construct implanted during the initial surgery.Lumbar 4-5-sacral 1 pedicle screws with cross connector.
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Manufacturer Narrative
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The investigation was completed with the returned construct parts and the information available.A review of the manufacturing records did not find any issues which would have contributed to this event.The root cause of this event cannot be conclusively determined, however, as the hardness and micrographic structure were tested and shown to be perfectly consistent with a ta6v-type titanium alloy, it is likely that the device broke following a phenomenon of progressive cracking attributable to repeated cyclic flexion.
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Search Alerts/Recalls
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