MEDPOR CONTAIN SHEET 25MM X 30 81064

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-17 for MEDPOR CONTAIN SHEET 25MM X 30 81064 manufactured by Stryker Cmf-georgia.

Event Text Entries

[16598714] Surgeon removed medpor contain implant from the patient due to infection.
Patient Sequence No: 1, Text Type: D, B5


[16669175] Device not returned for evaluation as it was discarded by the hospital. If additional information is received it will be reported on a supplemental report. (b)(4): device not returned.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0008010177-2013-00067
MDR Report Key3064538
Report Source05
Date Received2013-04-17
Date of Report2013-03-15
Date of Event2013-03-15
Date Mfgr Received2013-03-15
Date Added to Maude2013-04-18
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. JAMSHED BADARPURA
Manufacturer StreetMICRO IMPLANTS 750 TRADE CENTRE WAY SUITE 200
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693245346
Manufacturer G1STRYKER CMF-GEORGIA
Manufacturer Street15 DART ROAD
Manufacturer CityNEWNAN GA 30265
Manufacturer CountryUS
Manufacturer Postal Code30265
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDPOR CONTAIN SHEET 25MM X 30
Generic NameIMPLANT
Product CodeNPK
Date Received2013-04-17
Catalog Number81064
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER CMF-GEORGIA
Manufacturer Address15 DART ROAD NEWNAN GA 30265 US 30265


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-17

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