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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X105MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 30600105S
Device Problem Failure to Osseointegrate (1863)
Patient Problem Failure of Implant (1924)
Event Date 09/03/2014
Event Type  Injury  
Manufacturer Narrative
The reported event lag screw, ti gamma3® ø10. 5x105mm was alleged revised could not be confirmed since the device was not returned for evaluation and no other evidences were provided. 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. This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible and no additional information is not available. A review of the labeling did not indicate any abnormalities. If any further information is provided, the investigation report will be updated. Device not available to stryker.
 
Event Description
The manufacturer became aware of adverse events from the (b)(4) hip fracture register. The title of this report is ¿gamma 3 in the (b)(4) hip fracture register¿ which is associated with the gamma3 locking nail system, within that report, postoperative 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 nonunion. The patient received a hip bipolar hemiarthroplasty. Seventy-nine out of 290 cases.
 
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Brand NameLAG SCREW, TI GAMMA3® Ø10.5X105MM
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 Key7746389
MDR Text Key115902405
Report Number0009610622-2018-00464
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number30600105S
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: 08/03/2018 Patient Sequence Number: 1
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