Catalog Number 04.503.638.01S |
Device Problems
Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Not explanted.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.Device history records was conducted.The report indicates that the: 04.503.638.01s / lot 9273378, manufacturing location: (b)(4), manufacturing date: 3rd december 2014, expiry date: 1st november 2024, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was found on (b)(6) 2015 that locking screws implanted in the patient's mandible have been loosened.The patient had the initial surgery on (b)(6) 2015.This report is 2 of 9 for (b)(4).
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Manufacturer Narrative
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(b)(4).(b)(6).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Additional narrative: product investigation summary: the following devices were received for evaluation: part 04.503.638.01s / lots 9273378, 9369363, 9213139, 9273378, 9273378 (x5).Part 04.503.640.01s / lot 9213139, 9257974 (x2).Part 04.503.642.01s / lot 9219272 (x1).Part 04.503.644.01s / lot 9279387 (x1).The shaft and head threads as well as the recess and tip sections show slight marks of use.Based on the surgical technique, the device specific adverse events of loosening, bending, or breakage of the device can occur.The exact cause for the loosening of the screws could not be determined.It is likely that bone movement and/or insufficient tightening of the screws in the plate led to loosening.No manufacturing-related failures were detected.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Update: the complainant part was returned, indicating that a revision procedure was performed.No additional information was provided regarding this information.
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Search Alerts/Recalls
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