Catalog Number 482316040 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Defective Device (2588); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)
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Patient Problems
Pain (1994); Injury (2348); Ambulation Difficulties (2544)
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Event Date 10/14/2016 |
Event Type
Injury
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Event Description
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It was reported that; on december 5, 2015, the patient underwent a 6-level spinal fusion (t10-l3) and a 3-level revision (l4-s1).The surgeon performed the surgery using products.Approximately 3 months after the surgery, the double-lock screw caps began to fail, causing the screws at l1-l2 to back out of place and the hardware to fall out of alignment.On (b)(6) 2016, the surgeon operated to replace the defective hardware and used triple-lock screw caps to secure the new hardware.My son continued to have constant pain and mobility problems.Further ct scans revealed the double-lock screw caps, from the (b)(6) surgery, at l4-s1 had failed.This hardware failure caused the screws to back out of place and the hardware to fall out of alignment.In addition, some of these screws were holding a rod in place.Without the screws holding it in place, the rod was literally banging around the base of the spine.On (b)(6) 2016, the surgeon replaced all the defective hardware, replaced the rod which was now damaged, and used the triple-lock screw caps to hold everything in place.These two surgeries caused the patient extreme pain, all because of hardware failures.
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Manufacturer Narrative
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Catalog# 482316040.Method: risk assessment.Results: device history, device evaluation and complaint history review could not be performed as no lot code was provided and the product was not returned.Conclusion: the exact root cause could not be determined because the devices were not returned for evaluation.
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Event Description
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It was reported that; on (b)(6) 2015, the patient underwent a 6-level spinal fusion (t10-l3) and a 3-level revision (l4-s1).The surgeon performed the surgery using products.Approximately 3 months after the surgery, the double-lock screw caps began to fail, causing the screws at l1-l2 to back out of place and the hardware to fall out of alignment.On (b)(6) 2016, the surgeon operated to replace the defective hardware and used triple-lock screw caps to secure the new hardware.My son continued to have constant pain and mobility problems.Further ct scans revealed the double-lock screw caps, from the (b)(6) surgery, at l4-s1 had failed.This hardware failure caused the screws to back out of place and the hardware to fall out of alignment.In addition, some of these screws were holding a rod in place.Without the screws holding it in place, the rod was literally banging around the base of the spine.On (b)(6) 2016, the surgeon replaced all the defective hardware, replaced the rod which was now damaged, and used the triple-lock screw caps to hold everything in place.These two surgeries caused the patient extreme pain, all because of hardware failures.
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Search Alerts/Recalls
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