Catalog Number 497.125 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/03/2014 |
Event Type
malfunction
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Event Description
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The surgeon was performing a vertical expandable prosthetic titanium rib exchange procedure.The surgeon exchanged the lumbar extension rod as it was expanded all the way.The surgeon applied the small stature rib hook and needed to remove it to bend the lumbar extension more.The hook would not remove and the surgeon assessed the set screw was broken somehow.The surgeon removed the entire device and did not replace it.Prior to the rib hook the table top cutter broke at the thread of the handle while cutting the rod.The universal spine system handle broke while trying to load a universal spine system stick to screw.There was no reported patient harm.There was a 20 minute delay in the procedure.The procedure was completed successfully.The patient status/outcome is reported as satisfactory.This is report 4 of 6 for (b)(4).
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Manufacturer Narrative
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Device is used for treatment not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This 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.
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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.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: a pd event evaluation was conducted.The report indicates that a small titanium rib hook (part 04.641.002, lot 7495437) was returned attached to a titanium proximal extension size 5 (part 04.641.055, lot 6440301), with the complaint that the hook would not remove and the surgeon assessed the set screw was broken somehow.The returned parts were examined and it was seen that the nut on the rib hook has external gouge markings along the entire circumference of the nut which indicate that it has seen excessive force and may be stripped.The diameter of rod portion of part 04.641.055 (lot 6440301) was measured and found to be within tolerance, therefore improper dimension of the proximal extension can be ruled out as a cause for this complaint.The drawings for this part were examined and there were no design changes required, and no changes have been made to the design since this part was released to the warehouse in october of 2013.The material is also found to be suitable for its intended use.This complaint for the rib hook is confirmed, however the proximal extension does not appear to be a factor for the complaint.The design and materials were found to be adequate for the intended use and did not contribute to the complaint condition.If the proper rib hook holder, veptr nut driver shaft and 5nm torque limiting handle were used in this procedure, then the nut should not have ended up over tightened and stripped to the point that the proximal extension could not be removed.The proxima extension (part # 04.641.055) is within specification and did not contribute to the reported failure.The returned device is considered a concomitant device.(b)(4).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: a review of device history records for manufacturing revealed no complaint related issues.Subject device has been received and is currently in the evaluation process.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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