2124215-2019-12398.Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2019 - 02617, 0001825034 - 2019 - 02619, 0001825034 - 2019 - 02620, 0001825034 - 2019 - 02621, 0001825034 - 2019 - 02622, 0001825034 - 2019 - 02623, 0001825034 - 2019 - 02624, 0001825034 - 2019 - 02625, 0001825034 - 2019 - 02626, 0001825034- 2019 - 02627.Concomitant medical products: product lot or serial description primary di# 815355070 lot unknown 5.5mm polyaxial screw ft 70mm (01) 00887868041853, 815355080 lot unknown 5.5mm polyaxial screw ft 80mm (01) 00887868041877, 815355060 lot unknown 5.5mm polyaxial screw ft 60mm (01) 00887868041839, 815355025 lot unknown 5.5mm polyaxial screw ft 25mm (01) 00887868041662, 815308075 lot unknown 8.0mm cann locking ft 75mm (01) 00887868041211, 815045540 lot unknown 4.5 locking shaft screw 40mm (01) 00887868040894, 815045536 lot unknown 4.5 locking shaft screw 36mm (01) 00887868040870, 815045514 lot unknown 4.5 locking shaft screw 14mm (01) 00887868040764, 815745036 lot unknown 4.5 x 36mm cortical screw ft (01) 00887868042416 , 814131106 lot 666670 femoral plate 6 hole left (01) 00887868036934. the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Upon reassessment of the reported event based on the additional information received, it was determined that the cause of death was due to anorexia, poor po intake ¿ patient was not eating or drinking enough to support/sustain life and was not due to the medical devices.Hence the initial report needs to be voided.
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It was further reported upon review the patient expired due to natural causes, and the devices were not alleged to have contributed, according to the medical documentation.Cause of death was: anorexia, poor po intake ¿ patient was not eating or drinking enough to support/sustain life.Significant conditions contributing to but not causing death: hyponatremia, gerd, copd, anxiety.
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