PCD PREC SYS LONG TUBE W/VPLX 0507486000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-04 for PCD PREC SYS LONG TUBE W/VPLX 0507486000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[182023574] Discarded.
Patient Sequence No: 1, Text Type: N, H10


[182023575] It was reported that black rubber from the cement mixer became loose and mixed with the cement. There was a delay of a couple of hours to get a new device. The procedure was completed successfully with no adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2020-00610
MDR Report Key9788154
Report SourceUSER FACILITY
Date Received2020-03-04
Date of Report2020-03-04
Date of Event2020-02-04
Date Mfgr Received2020-02-06
Date Added to Maude2020-03-04
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. ZACH BAKER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-PUERTO RICO
Manufacturer StreetLAS PALMAS INDUSTRIAL PARK HIGHWAY #3, KM 130.2
Manufacturer CityARROYO 00615
Manufacturer CountryPR
Manufacturer Postal Code00615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePCD PREC SYS LONG TUBE W/VPLX
Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeNDN
Date Received2020-03-04
Catalog Number0507486000
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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