Device was used for treatment, not diagnosis.(b)(4).Broken plate was implanted on an unknown date.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: manufacturing location: (b)(4).Manufacturing date: june 16, 2015, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the 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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It was reported that a revision surgery was performed because of a non-union on (b)(6) 2015 to remove a broken 4.5mm va-lcp curved condylar plate/10 hole/230mm/right.The lcp curved condylar plate, implanted on an unknown date, was discovered broken with the use of x-rays and a surgery was scheduled to remove the broken implant and revise the non-union.There was no delay in surgery and the patient remained in good health post-surgery.This report is 1 of 1 for com-(b)(4).
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Product investigation summary: the following device(s) were received: 4.5mm va-lcp curved condylar plate (part # 02.124.410 | lot # 9508534) eleven (11) intact screws ¿ part numbers: 02.231.670 (x2), 02.231.665, 02.231.655, 02.205.270, 214.836 (x4), 214.834 (x2).A total of twelve (12) implants were received.The plate was severely bent and nearly broken into two pieces at the fourth combi-hole from the head portion of the plate.An inspection of the fracture site shows material homogeneity.The received screws were intact and functionally undamaged.Although the exact cause for the complaint condition cannot be determined, it is likely that excessive, cyclic loading due to insufficient/delayed bone healing resulted in the plate bearing the entire functional load of the patient.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The 4.5mm va-lcp curved condylar plate is indicated for buttressing multi-fragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, non unions and malunions.Proper use for the device(s) is addressed in the technique guide.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design was 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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