OBERDORF : SYNTHES PRODUKTIONS GMBH 6.0MM TI HARD ROD 75MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 498.103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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Patient gender and weight not available for reporting.Date reaction began is not known.Additional product codes: mni, mnh, kwp, kwq.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Facility address not available for reporting.Device is not distributed in the united states, but is similar to device marketed in the usa.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 was implanted with a 6.0mm titanium hard rod, a titanium universal spine system (uss) low profile fracture clamp, and a 6.2mm titanium schanz screw with dual core on (b)(6) 2016 for a column fracture at t12.On unknown date patient presented with a skin reaction comparable with an allergy.Reaction was treated for almost a year with antihistamines but proved difficult to control.A biopsy was performed on unknown date, results are not known.Patient currently maintains slight skin lesions on the thighs and legs.This report is for one (1) 6.0mm titanium hard rod.This is report 3 of 3 for (b)(4).
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Manufacturer Narrative
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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.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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