UNKNOWN_FRO_PRODUCT UNK_FRO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-02-16 for UNKNOWN_FRO_PRODUCT UNK_FRO manufactured by Stryker Orthopaedics-limerick.

Event Text Entries

[100307432] The device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Source of information was a retrospective study involving patients treated between feb. 2012 and 2015, so expected that all explanted material was discarded.
Patient Sequence No: 1, Text Type: N, H10


[100307433] It was noted through a medical publication during a collateral material review that an infection occurred after the completion of a mandibular surgical procedure involving the use of a calcium phosphate paste. The study indicates eight patients contracted an infection, but a revision surgery was not required in any of those cases. No other information is known.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008010177-2018-00019
MDR Report Key7277901
Report SourceOTHER
Date Received2018-02-16
Date of Report2018-07-12
Date of Event2016-05-25
Date Mfgr Received2018-01-18
Date Added to Maude2018-02-16
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. GREGORY GOHL
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER ORTHOPAEDICS-LIMERICK
Manufacturer StreetRAHEEN BUSINESS PARK
Manufacturer CityLIMERICK NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN_FRO_PRODUCT
Generic NameIMPLANT
Product CodeGXP
Date Received2018-02-16
Catalog NumberUNK_FRO
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS-LIMERICK
Manufacturer AddressRAHEEN BUSINESS PARK LIMERICK NA NA


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-16

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