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Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Aditional product code: kwp.Device not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number, the device history record review and 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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Device report from synthes on an event in (b)(6) as follows: it was reported that post-operative the cervifix occiput rod broke.The implantation was performed on (b)(6) 2016.It was decided to add a second part for an unknown rod that was broken post-operatively too as it was visible on the x-rays.No information available about patient condition, outcome or if a revision surgery was performed.The surgeon did not perform a revision surgery yet.This complaint involves 2 parts.Concomitant medical products: 5x locking cap (part and lot unknown); 5x pedicle screw (part and lot unknown); 1x locking screw axon (part 406.104 lot 9824135); 3x cortex screw (part and lot unknown); 3x cortex screw (part 404.310 lot 9401671, part 404.310 lot 3277548, part 404.312 lot 9789709).This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(4).This report is for one (1) unknown rod.Part and lot numbers are unavailable for reporting.Other number¿udi: part number unknown, udi is unavailable.Additional device product codes are mnh, mni and kwq.510(k): a 510(k) number was reported in error in the initial medwatch report #(b)(4).A 510(k) number cannot be identified without a part number.This field should have remained blank as the 510(k) number is unknown.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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Search Alerts/Recalls
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