SYNTHES MEZZOVICO 3.5MM TI CURVED ROD 30MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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Catalog Number 04.614.730 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Foreign Body Sensation in Eye (1869); Headache (1880); Unspecified Infection (1930); Pain (1994); Dizziness (2194)
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Event Type
Injury
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Manufacturer Narrative
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Patient height reported as 5¿4¿.Additional product codes: mnh, mni, kwp.(b)(4).Device is not explanted.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.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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It was reported patient underwent two (2) prior revisions of competitor¿s hardware for anterior cervical fusion (acf) on (b)(6) 2016.After seeking treatment from another surgeon, patient was then implanted with synthes hardware: two (2) 3.5mm titanium curved rods, four (4) 3.5mm titanium cancellous polyaxial screws, and four (4) titanium locking screws.Patient was also implanted with an unknown spacer; it is not believed the spacer is a synthes product.Two (2) weeks following implant procedure, patient reports hearing a loud pop.An unplanned follow up visit to the surgeon revealed patient had an incisional infection.Patient was treated with oral antibiotics and told to use ice and heat for the pop and pain.Patient reports continued incisional pain, dizziness, fatigue, and headaches.Patient further reports being able to feel the implant if tilting her head back.Patient continues to be treated with hydrocodone and valium, and was schedule for a computed tomography (ct) scan on (b)(6) 2017.Devices remain implanted at this time.Concomitant devices reported: spacer (part number unknown, lot number unknown, quantity 1).This report is for one (1) 3.5mm titanium curved rod 30mm.This is report 2 of 10 for (b)(4).
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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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Search Alerts/Recalls
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