(b)(4).Concomitant medical products: 180322, maestro tc capitatestem 6x18mm, 013330; 180363, maestro tc carpalhd 7x15mm std, 818610; 180482, maestro radial stem 7.5x60mm, 738690; 180151, maestro rad w/brg 7x15 7.5 rt, 217150; 180304, maestro tc carpalpt 9x37 9 aug, 837790; 180352, variable lock screw 4.75x25mm, 551330; 180355, variable lock screw 4.75x40mm, 551300; 180357, variable lock screw 4.75x50mm, 872250.Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04268; 0001825034 - 2018 - 04269; 0001825034 - 2018 - 04270; 0001825034 - 2018 - 04271; 0001825034 - 2018 - 04266; 0001825034 - 2018 - 04273; 0001825034 - 2018 - 04274; 0001825034 - 2018 - 04275.Product location unknown.
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It was reported that the patient¿s original wrist replacement had to be removed due to infection and caused the carpals to be damaged enough that a standard plate would not work.Subsequently, the surgeon requested a patient matched carpal plate to get a new wrist replacement.In addition, the surgeon believes the risk of infection coming back to the pointer finger requires custom screw placement.No further information has been provided.
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