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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 33250400S
Device Problem Failure to Osseointegrate (1863)
Patient Problem Inadequate Osseointegration (2646)
Event Date 10/06/2016
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report. Device disposition is unknown.
 
Event Description
The manufacturer became aware of adverse events from the norwegian hip fracture register. The title of this report is ¿gamma 3 in the norwegian hip fracture register¿ which is associated with the gamma 3 locking nail system, within that report, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 and 31-dec-2016. A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report. This product inquiry addresses revision surgery due to osteosynthesis failure. Re-osteosynthesis was performed. Case 5 out of 290 cases.
 
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Brand NameLONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7771581
MDR Text Key116701698
Report Number0009610622-2018-00624
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number33250400S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
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: 08/10/2018 Patient Sequence Number: 1
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