Device was used for treatment, not diagnosis.Patient initials are: (b)(6).Patient age and weight not available for reporting.Unknown when pain, non-union or breakage occurred.Additional product code: mni.(b)(4).(b)(4): this event resulted in delayed healing and pain, and required additional surgical intervention to remove the broken hardware.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that a patient had surgery on (b)(6) 2015 to treat a sacral u fracture and also a pelvis fracture.In this initial surgery the patient had a posterior spinal fusion and was instrumented with uss fracture at l5, skipped s1 due to fracture, and was instrumented in the ilium with synthes uss (bilateral construct).The patient also had a 7.3 x 155mm cannulated ss synthes ortho screw placed transsacral.The patient did not heal and at an unknown point in time the patient broke both rods just cranial to the iliac screws.The patient also broke the 7.3 x 155mm cannulated screw.In additional, pain, irritation and discomfort was reported.It is unknown where the location of the pain is.On (b)(6) 2016, the spine surgeon performed the revision.He removed all the hardware from the (b)(6) 2015 procedure, which included the two broken rods.The spine surgeon then reinstrumented the patient with depuy expedium 5.5mm rod system.He replaced both l5 screws, replaced both iliac screws, and then placed 2 more iliac screws alongside of the others.He placed new rods and successfully completed the procedure.After the spine surgeon had completed the spine part of the procedure, the ortho trauma surgeon came in and removed the two (2) broken pieces of the 7.3mm x 155mm cannulated screw and placed a new cannulated screw and successfully completed the procedure.There was no report of any surgical delay and patient status is unknown.This complaint involves 3 parts.This report is 2 of 3 for (b)(4).
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