The build lhr for h80008060 abh009 and h80007539 abe440 was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with these lots.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management file review identified no new risks associated with the device.Rmf 0003 rev 36 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants rmf 0003 rev 36 line 12.75 - device explanted.
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The build lhr for h80008060 abh009 and h80007539 abe440 was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with these lots.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management file review identified no new risks associated with the device.Rmf 0003 rev 36 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 36 line 12.75 - device explanted.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, and the provided radiographic images, the devices showed clear evidence of in vivo mechanical failure after the reported 12-13 years.The devices had collapsed, the sheaths had cleaved, and the endplates at c5/6 were no longer attached to each other and c6-7 endplates were only loosely attached.Furthermore, there was evidence of abrasive contact between the endplates.Without interim radiographs, it was not possible to determine the sequelae of events that led to the failure of this pe.
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