Model Number 48230000 |
Device Problems
Fracture (1260); Loose or Intermittent Connection (1371); Difficult To Position (1467)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/28/2018 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure, the tulip head on the screws was loose and would not take a blocker.One of the blockers that was tried, was severed at an angle.The two screws were taken out and replaced.There was a 30 minute surgical delay.There were no adverse health consequences to the patient.
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Manufacturer Narrative
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The customer reported event was confirmed via correspondence.The device was discarded at the hospital, so device inspection could not be performed.No lot number was provided, so a manufacturing record review could not be completed.Conclusion: per what was reported, not stryker product was used to tighten the blocker.According to the ifu, "stryker spine implants may only be implanted with the appropriate instruments supplied by stryker spine.Stryker spine shall not be liable for implants implanted using other manufacturer¿s instruments." the most likely root causes are deviation from the surgical technique by using a non stryker spine torque wrench and possibly misalignment of the blockers during tightening.A definite root cause cannot be determined however as the devices were not returned for evaluation.
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Event Description
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It was reported that during a procedure, the tulip head on the screws was loose and would not take a blocker.One of the blockers that was tried, was severed at an angle.The two screws were taken out and replaced.There was a 30 minute surgical delay.There were no adverse health consequences to the patient.
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Search Alerts/Recalls
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