CMF CUSTOMIZED IMPLANT KIT LARGE 5444-0-300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-22 for CMF CUSTOMIZED IMPLANT KIT LARGE 5444-0-300 manufactured by Stryker Orthopaedics Mahwah.

Event Text Entries

[20735271] The surgeon was putting the second or third screw into the implant and as the screw was tightening the implant cracked. They ended up implanting the product and the screw continued to hold.
Patient Sequence No: 1, Text Type: D, B5


[20909058] An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer. Additional information pertaining to the device(s) referenced in this report (including x-rays and medical records) was requested. Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2249697-2011-01654
MDR Report Key2397404
Report Source07
Date Received2011-11-22
Date of Report2011-11-02
Date of Event2011-11-01
Date Mfgr Received2011-11-02
Date Added to Maude2012-03-27
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 ContactJADWIGA DEGRADO
Manufacturer Street325 CORPORATE DR.
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER ORTHOPAEDICS MAHWAH
Manufacturer Street325 CORPORATE DR.
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal Code07430
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCMF CUSTOMIZED IMPLANT KIT LARGE
Generic NameIMPLANT
Product CodeKWO
Date Received2011-11-22
Model NumberNA
Catalog Number5444-0-300
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS MAHWAH
Manufacturer AddressMAHWAH NJ 07430 US 07430


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-11-22

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