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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1896-5050S
Device Problems Break (1069); Fracture (1260)
Patient Problems Ambulation Difficulties (2544); Implant Pain (4561)
Event Date 02/27/2022
Event Type  Injury  
Event Description
As reported: "the patient underwent emergency surgery on (b)(6) 2022 and returned to the emergency room on (b)(6) 2022 presenting pain and difficulty in locomotion in which after x-ray it was evidenced that the distal screw was broken. ".
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
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Brand NameLOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
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 Key13951405
MDR Text Key288210710
Report Number0009610622-2022-00109
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K203819
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1896-5050S
Device Catalogue Number18965050S
Device Lot NumberK0B8661
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? No
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: 03/30/2022 Patient Sequence Number: 1
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