UNKNOWN SMART TOE UNK_SEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for UNKNOWN SMART TOE UNK_SEL manufactured by Stryker Gmbh.

Event Text Entries

[99768947] Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10


[99768948] As reported, rep was contacted (b)(6) 2018 by a surgeon in regards to stryker smart toe implants (no specific part/ lot numbers). Surgeon stated he has experienced 10-12 implant failures in 100 cases he has utilized the system. I haven't covered his cases since 2013 (at his request). As a result, i was unaware of these failures until now. This event is for case 12 of 12.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2018-00115
MDR Report Key7261501
Date Received2018-02-09
Date of Report2018-02-09
Date of Event2018-01-16
Date Mfgr Received2018-01-16
Date Added to Maude2018-02-09
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. ROSE HAAS
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN SMART TOE
Generic NameIMPLANT
Product CodeKWH
Date Received2018-02-09
Catalog NumberUNK_SEL
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-02-09

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