Model Number SY633TS |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: up to now there is no sample available.Therefore, there is no investigation possible.Device history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are currently no further complaints with this lot and error pattern at hand.The current failure rate is within the risk analysis and therefore acceptable according to procedures; severity was 4(5) and probability 2(5).Conclusion and preventive measures: based upon the investigation results, a clear root cause cannot be determined.Multiple quality checks are performed on the product, and a material or manufacturing defect is unlikely.In the future, if the product is returned, another investigation will be performed at that time.Based upon the investigation results, a capa is not necessary.
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Event Description
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It was reported that there was an issue with sy633ts - ennovate polyax.Screw 6.5x40mm canulated.According to the complaint description, after inserting the screws into l4 and l5 of the lumbar vertebrae, the screws and rods were attached using a rod pusher.However, the screws came out on only one side, so they were replaced with 7.5 mm products.There was temporary impairment; possibility of screws coming loose.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2023-00217 ((b)(6) + sy633ts), 9610612-2023-00219 ((b)(6) + sy633ts).
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Search Alerts/Recalls
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