SST EZ SPHERE - 22MM 80014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-31 for SST EZ SPHERE - 22MM 80014 manufactured by Stryker Orthobiologics-malvern.

Event Text Entries

[90714523] Device is not available for evaluation. If additional information is received it will be reported on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[90714524] It was reported by hospital pharmacist through a company representative that a patient developed a possible post-surgical infection related to a major orbital inflammatory syndrome after a surgical procedure with an implant. The procedure had been completed successfully without a delay. It was reported the patient returned to the hospital and additional medical intervention was administered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008010177-2017-00272
MDR Report Key6991668
Report SourceHEALTH PROFESSIONAL
Date Received2017-10-31
Date of Report2018-04-17
Date of Event2017-09-29
Date Mfgr Received2017-10-02
Device Manufacturer Date2017-05-08
Date Added to Maude2017-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KELLI DYKSTRA
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER ORTHOBIOLOGICS-MALVERN
Manufacturer Street45 GREAT VALLEY PARKWAY
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal Code19355
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSST EZ SPHERE - 22MM
Generic NameIMPLANT
Product CodeFWP
Date Received2017-10-31
Catalog Number80014
Lot NumberA1702029
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOBIOLOGICS-MALVERN
Manufacturer Address45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-10-31

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