Catalog Number 04.632.000 |
Device Problems
Loose or Intermittent Connection (1371); Device Slipped (1584); Fitting Problem (2183)
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Patient Problems
Failure of Implant (1924); Sedation (2368)
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Event Date 01/14/2015 |
Event Type
Injury
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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that all 6 screws has loosen in spite of using the torque limiter.On the left site the rod is slip out from the last screw cranial.On the right site the rod was minimal fixed on the last screw cranial.A second surgery of 120 minutes was necessary.This report is 7 of 14 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional product code: mnh, mni, kwq, kwp.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested 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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(b)(6).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: it was reported that the explanted matrix system was substituted with the uss fracteur during the revision procedure.
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Manufacturer Narrative
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A manufacturing investigation was performed for the subject device.The matrix locking cap (subject device) and component exhibits post production/acceptance damage that includes: the majority of the m10x1.25 thread on the locking screw has visual mechanical damage and is missing anodized coating.The sd25 face has nicks and visual damage to the form in the sd25 pocket.There are nicks at the bottom of the sd25 pocket indicating that the driver was able to go to depth.The saddle has visual damage to the locking thread with damage to both wings.All described non-conformities/damage are not related to the manufacturing process.No indication for material or design related issue was found.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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Review of the device history records showed there were no issues during the manufacture that would contribute to this complaint condition.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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Event Description
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A review of the x-rays was completed: the post-operative x-rays (two views) and x-rays of implants after failure (two views) and the x-rays appear to match the complaint description of left rod slipping out of screw and right rod also appearing to have slipped compared to original position.It is difficult to comment with certainty on the status of the set screws by comparing the x-rays.
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Manufacturer Narrative
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Subject device has been received and is currently in the evaluation process.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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Search Alerts/Recalls
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