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Model Number 71701016L |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ossification (1428)
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Event Type
Injury
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Manufacturer Narrative
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Reference number: case (b)(4).
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Event Description
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It was reported that, after a primary trauma surgery had been performed on the patient's left hindfoot on (b)(6) 2016, in which a hfn 10mm x 16cm right nail was implanted along with four screws placed across the proximal tibial (x2), distal talar (x1) and distal posteroanterior (x1) region to treat a tibial pilon fracture with valgus deformity, the patient experienced a tibial cortical hypertrhophy.A complete fusion in the treated hindfoot joints was confirmed by x-ray assessment 3 months postoperatively.The reported incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information related to the patient's final outcome is not known and it is not possible to collect it.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation as the data collected from the post-market clinical follow up activity was anonymous.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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