SYNTHES USA TI MULTI-VECTOR DSTR PIN HLDG CLAMP/RAMUS-LIMITED BONE STOCK; SCREW FIXATION, INTRAOSSEOUS
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Catalog Number 487.942 |
Device Problems
Failure to Advance (2524); Unintended Movement (3026)
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Patient Problems
Airway Obstruction (1699); No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Event Description
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It was reported that there was a failure in advancement of a distractor from a planned bilateral mandibular distraction involving a neonate with pierre-robin sequence.The distractor was implanted on (b)(6) 2015 and there were no surgical delays reported.However, it was noted that there was a question as to whether the surgeon was able to complete the ostomy on the one side.When the patient was examined on (b)(6) 2015, the surgeon felt that the patient was not getting advancement and decided to make a mark on the distractor.Later that day, a second physician came in to check on the patient and noticed that the distractor had moved backwards.A decision was made to lock down the distractor so it would not reverse, therefore continuing with distraction.According to the physician, they were able to successfully obtain the advancement by activating then locking the distractor down.The second part of the procedure will be done very shortly (in approximately 6 weeks) and will entail the consolidation of rods.It was noted that there is the potential for an incomplete osteotomy.This report is 7 of 11 for (b)(4).
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Manufacturer Narrative
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Unknown patient information.Event date: unknown - date of post-operative non-advancement and distractor movement is unknown.Device has not been explanted; additional procedures where the device may be removed are to come.Complainant part is expected to be returned for manufacturer¿s review/investigation, but has yet to be received.(unintended movement) was included to reflect the backwards movement of the distractor as noted by the physician.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested/completed.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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Manufacturer Narrative
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(b)(4): five (5) component parts were removed during the revision procedure on (b)(6), 2015; it is unknown which of the 11 involved parts were explanted.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 second part of the procedure was completed on (b)(6), 2015.Five components were removed to put on consolidation rods.It was reported that after the consolidation rods were put on, the patient had to come back to surgery due to a decreased airway.New distractors had to be put on to continue distraction.
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Search Alerts/Recalls
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