InjuryNPK
MEDPOR CONTAIN IMPLANT
Received Jul 12, 2011
Report 1057129-2011-00023 · MDR key 2157561
Device
Generic name
Implant
Manufacturer
Stryker Craniomaxillofacial GeorgiaModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Extrusion
Patient
Not reported
- Erosion
Narrative
Additional Manufacturer Narrative
THE DOCTOR REPORTED SEVEN CASES WHERE THE MEDPOR CONTAIN SHEET IMPLANT WAS EXPOSED. THE DOCTOR PROVIDED LOT NUMBERS FOR FOUR OF THE CASES. THE LOT NUMBER INFORMATION FOR THIS CASE WAS NOT PROVIDED BY THE DOCTOR TO ALLOW FOR REVIEW OF THE DEVICE HISTORY RECORDS. 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.