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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LAG SCREW IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN LAG SCREW IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2013
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition unknown.
 
Event Description
Stryker became aware of the publication ¿inadequate ¿three-point¿ proximal fixation predicts failure of the gamma nail¿, published in the bone & joint journal which was published in june 2013 and is associated with gamma3 long and trochanteric nails. Within that publication 25 post-operative complications/ adverse events were reported, which occurred between 2006 and 2010. It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database however revealed that the events had not been reported by the hospital or by the author of the publication, therefore 25 complaints were initiated retrospectively. This product inquiry addresses a fixation failure: loss of fracture reduction with migration of the lag screw within the proximal fragment after 27 weeks of implantation of an unknown gamma3 long nail. Event 6 of 12.
 
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Brand NameUNKNOWN LAG SCREW
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7397537
MDR Text Key104405913
Report Number0009610622-2018-00166
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
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 Treatment Data
Date Received: 04/04/2018 Patient Sequence Number: 1
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