UNKNOWN STRYKER ELBOW UNK_JR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-21 for UNKNOWN STRYKER ELBOW UNK_JR manufactured by Stryker Orthopaedics-mahwah.

Event Text Entries

[133701114] It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[133701115] Patient called stating she had an elbow surgery done on (b)(6) 2017. Patient stated the screws came out and she is scheduled for a revision on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002249697-2019-00232
MDR Report Key8264409
Date Received2019-01-21
Date of Report2019-01-21
Date of Event2017-09-15
Date Mfgr Received2018-12-26
Date Added to Maude2019-01-21
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 FDA3
Event Location3
Manufacturer ContactMR. BRAD CURTIS
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER ORTHOPAEDICS-MAHWAH
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal Code07430
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN STRYKER ELBOW
Generic NameELBOW IMPLANT
Product CodeJDB
Date Received2019-01-21
Catalog NumberUNK_JR
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS-MAHWAH
Manufacturer Address325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-01-21

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