InjuryNPK

MEDPOR CONTAIN IMPLANT

Received Jul 12, 2011

Report 1057129-2011-00021 · MDR key 2157401

Device

Generic name

Implant

Manufacturer

Stryker Craniomaxillofacial Georgia

Model number

Catalog number

81064

Lot number

F046C03

Product problems

Extrusion

Patient

Not reported

Erosion

Narrative

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED AND ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT SPECIFICATION. DEVICE NOT RETURNED.

Description of Event or Problem

THE DOCTOR PLACED A MEDPOR CONTAIN SHEET IMPLANT AND AT APPROXIMATELY TWO TO THREE MONTHS THE PATIENT PRESENTED WITH EXPOSURE OF THE MEDPOR CONTAIN SHEET IMPLANT. THE DOCTOR REMOVED THE IMPLANT.