Catalog Number 305006 |
Device Problems
Collapse (1099); Fluid/Blood Leak (1250); Mechanical Problem (1384); Decrease in Pressure (1490)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/17/2016 |
Event Type
malfunction
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Event Description
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It was reported that; the surgeon starting turning the t-handle to expand the cage.The cage lifted some, but then the syringe body psi gauge started to release and pressure was lost.We then took off the syringe body and filled with saline again and processed to retry.As he turned the t-handle again, we noticed no water leaking from anywhere on the syringe, inserter or cage.The cage would start to expand and then it was as if intermittently the pressure would hold and then release while the gauge showed just barely in the yellow section.It did not seem as though we hit the 2000 psi required to release the pressure either.This delayed the case by about 5 minutes.We tried one last time to refill the syringe body and expand the cage; it expanded what seems to look like 9mm, the maximum for this cage.However, surgeon kept feeling like pressure would hold one second and then try and release another, so the confidence of the expansion was questioned.There were no adverse effects to the patient and once surgeon reached what seemed to be full expansion, we disconnected the inserter from the cage and continued on with the case.Returning syringe body and tubing only; cage was implanted.Updated: 2 weeks post op the cage collapse.There is no plan for a revision surgery, and no adverse consequences reported.
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Manufacturer Narrative
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Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Based on the fatigue testing results, the surgeon must consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact the performance of the intervertebral body fusion device.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G.Substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Sales rep reported that the surgeon was hesitant to provide information regarding patient's lifestyle, operative notes and clinical history.According to instruction for use patient activity level and life style may be contributing factors of possible device failure.Conclusion: failure of the implant could not be confirmed conclusively therefore a plausible root cause could not be identified.
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Event Description
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It was reported that; the surgeon starting turning the t-handle to expand the cage.The cage lifted some, but then the syringe body psi gauge started to release and pressure was lost.We then took off the syringe body and filled with saline again and processed to retry.As he turned the t-handle again, we noticed no water leaking from anywhere on the syringe, inserter or cage.The cage would start to expand and then it was as if intermittently the pressure would hold and then release while the gauge showed just barely in the yellow section.It did not seem as though we hit the 2000 psi required to release the pressure either.This delayed the case by about 5 minutes.We tried one last time to refill the syringe body and expand the cage; it expanded what seems to look like 9mm, the maximum for this cage.However, surgeon kept feeling like pressure would hold one second and then try and release another, so the confidence of the expansion was questioned.There were no adverse effects to the patient and once surgeon reached what seemed to be full expansion, we disconnected the inserter from the cage and continued on with the case.Returning syringe body and tubing only; cage was implanted.Updated: 2 weeks post op the cage collapse.There is no plan for a revision surgery, and no adverse consequences reported.
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Search Alerts/Recalls
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