Catalog Number VP1301.02 |
Device Problem
Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930)
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Event Type
malfunction
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Manufacturer Narrative
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Device used in a veterinary case - no patient information will be reported.Date of event: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6) device is a veterinary product, but is similar to device used on humans.Manufacturing location: bettlach.Supplier: (b)(4).Manufacturing date: february 12, 2015.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that an anterior cruciate ligament (acl) broke.On (b)(6) 2015: extracapsular stabilization by ligament graft (1/3 lateral patellar tendon + fascia lata) secured by washer screws on the lateral femoral condyle.On (b)(6) 2015: wound flowing.On (b)(6) 2015: x-ray: peek washer out of the screw, seroma.Excision and sending the washer to laboratory for bacteriological examination.On (b)(6) 2015: takeover by plateau leveling osteotomy (tplo).On (b)(6) 2016: tplo infection.To this day: total bone healing and infection.This report is for a veterinary case; there was no human patient involvement.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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(b)(4) infection, reported incorrectly.The infection events are being captured under linked complaints (b)(4).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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The wound flowing on (b)(6) 2015 may have been due to escherichia coli.The washer and screw were explanted on (b)(6) 2015.On (b)(6) 2015, there was an implantation of a new plate and screws (tplo) because the initial screw wasn't holding on the ligament; it is unknown if these were synthes devices.This report is related to linked complaints (b)(4) which capture the infections.
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Manufacturer Narrative
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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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In regards to the screw not holding the ligament, it was noted by the manufacturer that the washer is indeed what is holding the ligament/tendon/graft, not the screw.The washer must be secured in proper location with the screw, but since the metal screw would not deform or move, the washer gave way.Therefore, no failure on the part of the screw.Concomitant reported part: 1 screw (part and lot number unknown).
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Search Alerts/Recalls
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