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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN EXTERNAL FIXATORS - HOFFMANN II; IMPLANT

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STRYKER GMBH UNKNOWN EXTERNAL FIXATORS - HOFFMANN II; IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Insufficient Information (3190)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/01/2009
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report."dispositon" is unknown.
 
Event Description
The manufacturer became aware of a study from kobe university graduate school of medicine, kobe, japan.The title of this report is ¿ankle arthrodesis using antegrade intramedullary nail for salvage of nonreconstructable tibial pilon fractures¿, which was published on 1-august-2009 and is associated with external fixators - hoffmann ii.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device or patient information from the report; a review of the complaint handling database, however, revealed that the events have not been reported previously.Therefore, 2 complaints were initiated retrospectively for the adverse events mentioned in the report.This product inquiry addresses unacceptable reduction.1 out of 2 cases.
 
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Brand Name
UNKNOWN EXTERNAL FIXATORS - HOFFMANN II
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8084323
MDR Text Key127562154
Report Number0008031020-2018-00995
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/31/2018
Initial Date FDA Received11/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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