SYNTHES BRANDYWINE 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 04.632.740 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Original implant surgery date was: (b)(6) 2016.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: dhr review for part#04.632.740 lot#7937087 releases to warehouse date: 25-feb-2015, manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this 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 reported that during a posterior fusion with matrix pedicle screws and rods at the l4-s1 level, while the surgeon was adjusting the tuliphead portion of the screw with the head turner instrument, the shaft portion of the screw was backing out creating an inability to seat the rod.The screws were removed and different screws were provided to the surgeon to complete the surgery.The procedure was completed successfully with no surgical delay and there was no patient harm.Operative report and x-rays are not available.There was no clinical factors.This complaint involves 2 parts.This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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An investigation summary was performed.The investigation of the complaint articles has shown that: two matrix polyaxial screws (04.632.740 lots 6986980 mfg 16-jul-2012 and 7937087 mfg 25-feb-2015) would not accept a rod as a result of misaligned collets.The procedure was able to be complete successfully, without surgical delay or patient harm, with immediately available alternate screws.The returned 7.0mm matrix polyaxial screws were examined and the complaint condition was able to be confirmed in each instance as the collets were found to be rotated.The received condition is consistent with the complaint description as the collet rotation would inhibit appropriate rod seating within the polyaxial screw and could potentially lead to a loose construct.No definitive root cause was able to be determined; the failure mode is typically associated with polyaxial head mobilization without the use of the polyaxial head alignment tool (03.632.007) allowing the polyaxial head to rotate irrespective of collet position.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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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