FEMORAL TRIAL DRILL GUIDE LM/RL 5650-1-712

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 2009-07-02 for FEMORAL TRIAL DRILL GUIDE LM/RL 5650-1-712 manufactured by Stryker Orthopaedics Mahwah.

Event Text Entries

[1263183] It was reported that, "guide ceased operating intraoperatively. "
Patient Sequence No: 1, Text Type: D, B5


[8279534] Additional info has been requested and if available, it will be submitted in the supplemental report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2249697-2009-00403
MDR Report Key1462070
Report Source07
Date Received2009-07-02
Date of Report2009-06-11
Date of Event2009-06-10
Date Mfgr Received2009-06-11
Device Manufacturer Date2008-01-08
Date Added to Maude2009-10-15
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 NameFEMORAL TRIAL DRILL GUIDE LM/RL
Generic NameINSTRUMENT
Product CodeLXI
Date Received2009-07-02
Returned To Mfg2009-06-17
Model NumberNA
Catalog Number5650-1-712
Lot NumberP2S39
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS MAHWAH
Manufacturer AddressMAHWAH NJ 07430 US 07430


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-07-02

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