At time of original surgery, surgeon implanted 7 clips, 2 plates and 1 screw.At time of revision surgery, 4 clips were found broken.Devices were not returned so therefore we are unable to properly identify the size and lot number of the failed components.Based on xrays, we have determined one 18mm x 14mm x 14mm clip was broke and 3 20mm x 20mm x 20mm clips were broke.There were no broken plates or screws.Per our investigation, we believe the hardware failure is due to patient conditions and use of product in a contraindicated condition.Failure of hardware is not unexpected in these sort of situations.Device not returned.
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