According to the investigation, the reduction guide was too fragile to be useful for the resection of the bone due to the position of implants close to the foramen.To correct for this the procedure would have been for the clinician to either omit some implants from the guide or to reposition them slightly away from the foramen.Although the pt was not harmed the surgical intervention was not completed as intended due to malfunction of the product.As such, the event is reportable per 21 cfr part 803.
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