Model Number P53-103-L252 |
Device Problems
Break (1069); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Identifying information of the part, such as the lot number of the device was not reported to paragon 28.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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Event Description
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It was reported that the patient underwent a surgical procedure on 11/15/2018 that utilized a paragon 28 gorilla plating system.The mtp plate was reported to have broken at the line of the precision guide placement.It was reported that a mtp graft was used for this case with the mtp plate.The patient was said to be non-complaint with post-operative instructions and weight bear early.The surgeon suspected possible infection however, the results were negative.It was reported that the surgeon may remove the hardware and place patient on antibiotics however, the revision was not scheduled.There was no reported harm to the patient due to the broken mtp plate.The patient is said to be a smoker and a diabetic.
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Search Alerts/Recalls
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