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Catalog Number UNKNOWN |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problems
Arthritis (1723); Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
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Event Date 09/22/2020 |
Event Type
Injury
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Event Description
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It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis, patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.Revision surgery was performed to correct the problem.
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Manufacturer Narrative
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It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis.The patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.A revision surgery was performed to correct the problem.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A review of risk management files found that the reported failure was documented appropriately.A medical analysis noted that two undated, unlabeled x-rays confirmed the stated failure.However, without the requested relevant clinical information, primary and revision report, trauma history, physical activity or the device the root cause of the reported loosening cannot be determined.Technique error of the prep or selection for the screws cannot be ruled out as well the quality of the bone as it could play a factor in this failure.Based on the limited information provided, the impact to the patient beyond the revision cannot be determined.Therefore, no further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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Manufacturer Narrative
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H3, h6: it was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis.The patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.A revision surgery was performed to correct the problem.The affected complaint device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device was inadvertently lost.The attached pictures of the device showed signs of damage from attempted use.Based off the evaluation of the plate and other screws , we have no reason to suspect this device contributed to the failure.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A medical analysis noted that two undated, unlabeled x-rays confirmed the stated failure.However, without the requested relevant clinical information, primary and revision report, trauma history, physical activity or the device the root cause of the reported loosening cannot be determined.Technique error of the prep or selection for the screws cannot be ruled out as well the quality of the bone as it could play a factor in this failure.Based on the limited information provided, the impact to the patient beyond the revision cannot be determined.Therefore, no further clinical/medical assessment is warranted at this time.Some potential probable causes for this event could include poor bone quality, a traumatic event or over-tightening of the screws.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.G1 mdr reporting contact name and address.
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