SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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Catalog Number 02.124.412 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Failure of Implant (1924); Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.The exact date of initial implant is unknown and was reported as an unknown date in (b)(6) 2015.The subject device is expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 three 5.0mm va (variable angle) locking screws (two most distal screws and a center head screw) backed out of a 12-hole va-lcp (variable angle locking compression plate) curved condylar plate.The two proximal head screws were fine.The plate and five screws were originally implanted on an unknown date in (b)(6) 2015.The patient was said to be non-compliant by walking and ultimately falling.Revision was scheduled due to implant failure (loosening), non-union, and pain, irritation, and discomfort.It appeared the threads in the two distal holes were slightly stripped.The va-lcp curved condylar plate was replaced with a lcp curved condylar plate on (b)(6) 2015.The surgery was successfully completed with no surgical delay.This report is 1 of 2 for com-(b)(4).
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Manufacturer Narrative
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Additional narrative: 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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Product investigation summary: a total of eleven (11) implants were received.All implants were intact and functionally undamaged.There were no issues found with any of them.The locking screws were tested in the locking holes on the head portion of the plate and all holes/locking screws functioned as intended.The exact cause for the complaint condition cannot be determined, but it was likely that the construct was subjected to excessive force due to the noncompliant patient.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The designs were determined to be suitable for the intended use when employed and maintained as recommended.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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Search Alerts/Recalls
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