FDA Device

ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.

Hazard

Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

What You Should Do

Remedy

Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.

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Products

ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-op
Brand
Materialise USA LLC
UPC
Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01

Units Affected

1

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