(b)(4) d10: medical products: item#: 00494500404, 4.5 mm t-plate 4 holes 84 mm length; lot#: unknown item#: unknown, unknown screw; lot#: unknown item#: unknown, unknown screw; lot#: unknown item#: unknown, unknown screw; lot#: unknown item#: unknown, unknown screw; lot#: unknown g2: foreign: italy no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: notes purulent material that reached/contaminated bone graft, removed plate & screws, i&d performed.Images not submitted to mmi for review, as the event is for infection and submitting images would not enhance the investigation process.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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