SST EZ SPHERE - 22MM 80014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for SST EZ SPHERE - 22MM 80014 manufactured by Stryker Orthobiologics-malvern.

Event Text Entries

[76044412] The device has not yet been received at the manufacturer for testing. An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[76044413] During the medpor packaging aging remediation (pretest) in the testlab in (b)(4), 1 sst ez sphere showed a particle in pouch.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008010177-2017-00114
MDR Report Key6592251
Date Received2017-05-25
Date of Report2017-12-28
Date of Event2017-04-27
Date Mfgr Received2017-04-27
Device Manufacturer Date2016-12-15
Date Added to Maude2017-05-25
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. 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 Report0

Device Details

Brand NameSST EZ SPHERE - 22MM
Generic NameIMPLANT
Product CodeFWP
Date Received2017-05-25
Returned To Mfg2017-06-19
Catalog Number80014
Lot NumberA1610025
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOBIOLOGICS-MALVERN
Manufacturer Address45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-25

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