UNKNOWN APEX PIN(3MM) UNK_SEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-03 for UNKNOWN APEX PIN(3MM) UNK_SEL manufactured by Stryker Gmbh.

Event Text Entries

[189081853] This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10


[189081854] The manufacturer became aware of a literature from erasme university hospital, belgium. The title of this report is? Secondary displacement of distal radius fractures treated by bridging external fixation? Which is associated with the stryker? Hoffman ii external fixator? System. Within that publication, post-operative complications/ adverse events were reported, which occurred from 2008 to dec 2009. It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 19 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses malunion. 2 out of 2 cases. The report states:? 5% of the patients ended up with a malunion.??
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2020-00256
MDR Report Key9661066
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-03
Date of Report2020-02-03
Date of Event2008-01-01
Date Mfgr Received2020-01-08
Date Added to Maude2020-02-03
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. ANNA JUSINSKI
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 Report3

Device Details

Brand NameUNKNOWN APEX PIN(3MM)
Generic NameIMPLANT
Product CodeJDW
Date Received2020-02-03
Catalog NumberUNK_SEL
Lot NumberUNKNOWN
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. Other 2020-02-03

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