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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 13200100
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem Injury (2348)
Event Date 10/25/2019
Event Type  Injury  
Manufacturer Narrative
Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.
 
Event Description
The customer reported that : " we put in a gamma nail this morning. We had a shift with the distal sight. " the customer further reported: "delay : 10 min longer than expected, fragile patient, no patient consequences medical intervention : removal of the screw settled next to the nail, bigger incision".
 
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Brand NameTARGET DEVICE GAMMA3® 300X160MM
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9355527
MDR Text Key167774742
Report Number0009610622-2019-00933
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200100
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 Received10/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/21/2019 Patient Sequence Number: 1
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