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Catalog Number UNK - SCREWS: MATRIXMANDIBLE |
Device Problem
Device Difficult to Maintain (3134)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review / investigation.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: cmf surgery on male 97 plate that was used matrixmandible subcondylar plate, thickness 1.0 mm, malleable, pure titanium.Screws that was used was cortex screw plusdrive¿ ø 2.0 mm, self-tapping.The problem that occurred was that the screws was to small for the plate.The surgeon had to use a different plate and the surgery time was prolonged ca 30 minutes.Unknown if fragments were generated or if surgery was delayed due to the reported event.It is also unknown if procedure was successfully completed.This complaint involves two (2) devices.This report is for one (1) unk - screws: matrixmandible.This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Concomitant medical products: device is not available - the customer is retaining the product.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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Search Alerts/Recalls
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