TPS XL OSCILLIATING SAW 5100131000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for TPS XL OSCILLIATING SAW 5100131000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[145114613] This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 2? Events were reported for this quarter. ? Product return status: 1 device was received. 1 device investigation type has not yet been determined. ? Event confirmation status: 1 reported event was confirmed; the cause traced to component failure. Evaluation results: 1 device was found to be affected by a missing component. ? Additional information: 2? Devices were not labeled for single-use. 2 devices were not reprocessed and reused.
Patient Sequence No: 1, Text Type: N, H10


[145114614] This report summarizes 2 malfunction events in which the device had a component detach. 2 events had no patient involvement; no patient impact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2019-01359
MDR Report Key8546020
Date Received2019-04-24
Date of Report2019-07-26
Date of Event2019-01-01
Date Mfgr Received2019-01-01
Date Added to Maude2019-04-24
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-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTPS XL OSCILLIATING SAW
Generic NameUNIT, OPERATIVE DENTAL
Product CodeEIA
Date Received2019-04-24
Catalog Number5100131000
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-24

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