(b)(4).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 - 02624, 0001825034 - 2019 - 02625, 0001825034 - 2019 - 02626, 0001825034- 2019 - 02627.Concomitant associated device(s): product, lot or serial, description, primary di: 815355070, lot: unknown, 5.5mm polyaxial screw ft 70mm, (b)(4); 815355080, lot unknown 5.5mm polyaxial screw ft 80mm, (b)(4); 815355060 , lot: unknown, 5.5mm polyaxial screw ft 60mm, (b)(4); 815355025, lot: unknown, 5.5mm polyaxial screw ft 25mm, (b)(4); 815308075, lot: unknown, 8.0mm cann locking ft 75mm, (b)(4); 815045540, lot: unknown, 4.5 locking shaft screw 40mm, (b)(4); 815045536, lot: unknown, 4.5 locking shaft screw 36mm, (b)(4); 815045514, lot: unknown, 4.5 locking shaft screw 14mm, (b)(4); 815745036, lot: unknown, 4.5 x 36mm cortical screw ft, (b)(4); 814131106, lot: 666670, femoral plate 6 hole left, (b)(4). 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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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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