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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3066-0095S
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 04/12/2022
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
As reported: "gamma3 primary surgery was performed on february 18, 2022 without any problem. Approximately two months postoperatively, the u-lug screw penetrated the femoral head. Revision surgery with bipolar was performed on (b)(6) 2022. ".
 
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Brand NameU-BLADE SET, TI GAMMA3® Ø10.5X95MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14318034
MDR Text Key291498631
Report Number0009610622-2022-00171
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540595997
UDI-Public04546540595997
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K200869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3066-0095S
Device Catalogue Number30660095S
Device Lot NumberK0D40BD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2021
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: 05/07/2022 Patient Sequence Number: 1
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