FDA.reportPublic FDA data

MAUDE MDR 8284710

MDR report key
8284710
Report number
0001811755-2019-00241
Event key
0
Event type
3
Date of event
2018-12-25
Date received
2019-01-29
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
1DUAL SPEED CEMENT INJECTION GUNMIXER, CEMENT, FOR CLINICAL USESTRYKER INSTRUMENTS-KALAMAZOOJDZ0206600000Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-290

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: 1 EVENT WAS REPORTED FOR THIS QUARTER. ? PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE IS NOT LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED AND REUSED.

D

Patient 1

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.