Model Number 48289745 |
Device Problems
Break (1069); Crack (1135); Fracture (1260); Defective Component (2292); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/17/2017 |
Event Type
malfunction
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Event Description
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It was reported that : "mounting l5-s1, inserting screws*, pedicular sight with square point, pedicle probe, palpator.Insert the screw with the redux screwdriver.Installation of the rod and nut.When inserting the nut into the l5 screw head then inserting the nut into the screw head in s1.On the left side, when the nut is inserted into the screw head in s1, the screw thread has "fouled".The surgeon tried to change the nut and insert the new nut into the screw head.By breaking the fins in s1, the surgeon noticed that the nut was not holding; the screw thread has "cracked" under the reduction thread.The surgeon therefore removed the nut in l5, then the stem to replace the screw in s1.* during the l5 pedicle sighting, the instrumentalist has mounted the screw on the redux screwdriver, the arms, redux vis dia.7.5 x 45 mm, sterile: 1 unit.Consequently, the instrumentalist used a new redux screw, surgical delay of 30 min".
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Manufacturer Narrative
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Method: visual inspection; device history review; complaint history review; risk assessment.Results: no relevant manufacturing issues were identified as all units met specifications.The device was inspected, and deformation was visible in the threading of the tabs attached to the tulip head.Conclusion: the most likely cause of the reported event was determined to be user error.
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Event Description
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It was reported that : "mounting l5-s1, inserting screws*, pedicular sight with square point, pedicle probe, palpator.Insert the screw with the redux screwdriver.Installation of the rod and nut.When inserting the nut into the l5 screw head then inserting the nut into the screw head in s1.On the left side, when the nut is inserted into the screw head in s1, the screw thread has "fouled".The surgeon tried to change the nut and insert the new nut into the screw head.By breaking the fins in s1, the surgeon noticed that the nut was not holding; the screw thread has "cracked" under the reduction thread.The surgeon therefore removed the nut in l5, then the stem to replace the screw in s1.* during the l5 pedicle sighting, the instrumentalist has mounted the screw on the redux screwdriver, the arms, redux vis dia.7.5 x 45mm, sterile: 1 unit.Consequently, the instrumentalist used a new redux screw, surgical delay of 30 min".
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Search Alerts/Recalls
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