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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2023-05-04Z-2064-2023Class IIOpen, ClassifiedDrill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.N/Acode info di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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