MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 179712640 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Udi #: (b)(4), unknown, unknown.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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Patient initiated complaint: it was reported on an unknown date, the patient underwent a laminectomy of t11-l3 due to a fracture at l1 is now showing symptoms of hypersensitivity to the metal installed in his back during the fusion.Reportedly, the patient is allergic to most other metals such as titanium hardware, but with her symptoms, this seems to be most likely the cause.Additionally, the patient wants to obtain a sample of the hardware or the sample of the material to verify if this is possibly what's causing the problems.The patient can provide the actual implant tracking sheet from the hospital if needed.There was no information of the surgical delay and patient consequence is unknown.This complaint involves ten (10) device.
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Search Alerts/Recalls
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