MEDPOR CONTAIN IMPLANT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-07-12 for MEDPOR CONTAIN IMPLANT UNK manufactured by Stryker Craniomaxillofacial Georgia.

Event Text Entries

[2070296] 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.
Patient Sequence No: 1, Text Type: D, B5


[9287019] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1057129-2011-00024
MDR Report Key2157593
Report Source05,07
Date Received2011-07-12
Date of Report2011-07-07
Date Mfgr Received2011-06-10
Date Added to Maude2011-07-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. JEFF WILLIAMS
Manufacturer Street15 DART ROAD
Manufacturer CityNEWNAN GA 302651017
Manufacturer CountryUS
Manufacturer Postal302651017
Manufacturer Phone7702544400
Manufacturer G1STRYKER CRANIOMAXILLOFACIAL GEORGIA
Manufacturer Street15 DART ROAD
Manufacturer CityNEWNAN GA 30265101
Manufacturer CountryUS
Manufacturer Postal Code30265 1017
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDPOR CONTAIN IMPLANT
Generic NameIMPLANT
Product CodeNPK
Date Received2011-07-12
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CRANIOMAXILLOFACIAL GEORGIA
Manufacturer Address15 DART ROAD NEWNAN GA 30265101 US 30265 1017


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-07-12

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