Model Number 48230000 |
Device Problems
Break (1069); Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Migration (4003)
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Patient Problems
Failure of Implant (1924); Injury (2348)
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Event Date 03/28/2018 |
Event Type
Injury
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Event Description
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A broken rod was reported post operatively.Pseudarthrosis mid thoracic t8-t9.Upon removal of rod, surgeon stated blockers seemed loose and rod was able to move with rod holder.Metallosis was noticed after removal of rod.
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Manufacturer Narrative
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The device was returned to stryker on (b)(6) 2018.Sections were updated with product information.
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Event Description
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A broken rod was reported post operatively.Pseudarthrosis mid thoracic t8-t9.Upon removal of rod, surgeon stated blockers seemed loose and rod was able to move with rod holder.Metallosis was noticed after removal of rod.
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Event Description
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A broken rod was reported post operatively.Pseudarthrosis mid thoracic t8-t9.Upon removal of rod, surgeon stated blockers seemed loose and rod was able to move with rod holder.Metallosis was noticed after removal of rod.
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Manufacturer Narrative
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Method: visual analysis, device history review, complaint history review, risk assessment; result: the blocker was inspected and there was a heavy rod indentation on the bottom of the blocker, indicating excessive tightening torque was applied.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported by the rep that a non stryker torque wrench was used to 12nm and it did not appear that the surgeon applied excessive force.The ifu states that "stryker spine implants may only be implanted with the appropriate instruments supplied by stryker spine".Examination of the implants found that the blockers were heavily deformed on the bottom, which is an indication that more than 12nm of force was applied to the blockers.This can deform the blocker and cause instability in the construct as the blocker is not optimally tightened and seated on the rod, which could cause it to loosen.Conclusion: the most likely root cause is deviation from the surgical technique as a non stryker torque wrench was used to final tighten the blockers.
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Search Alerts/Recalls
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