FDA.reportPublic FDA data

MAUDE MDR 9636501

MDR report key
9636501
Report number
0001811755-2020-00178
Event key
0
Event type
3
Date of event
2019-12-31
Date received
2020-01-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ZACH BAKER
Address
4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REVOLUTION CEMENT GUNMIXER, CEMENT, FOR CLINICAL USESTRYKER INSTRUMENTS-KALAMAZOOJDZ06066000000606600000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-280

Event Narratives#

N

Patient 1

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 16 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 8 DEVICES WERE RECEIVED. 8 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 8 REPORTED EVENTS WERE CONFIRMED. EVALUATION RESULTS 8 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. ADDITIONAL INFORMATION 16 DEVICES WERE NOT LABELED FOR SINGLE-USE. 16 DEVICES WERE NOT REPROCESSED OR REUSED.

D

Patient 1

THIS REPORT SUMMARIZES 16 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. 11 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO KNOWN PATIENT INVOLVEMENT OR PATIENT IMPACT. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.