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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X320MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X320MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3525-1320S
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Implant Pain (4561)
Event Date 08/10/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
It was reported that 3 months after implantation of a proximal femur nail, the material broke. Additional information received: "the patient presented to our orthopedic trauma surgery department on (b)(6) 2021 with increasing symptoms and status after implantation of the above product. By means of ct ((b)(6) 2021) a fracture of the nail at the level of the thigh screw penetration could be detected. According to the patient, she already noticed a cracking during the rehabilitation stay with an increase in pain. In the course of the subsequent x-ray control, no complications could be detected. Consequences: failure of the bone fracture to heal subtrochanterically, revision with complete removal of the marrow and re-implantation of a long intramedullary nail osteosynthesis on (b)(6) 2021. Another rehabilitation measures. ".
 
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Brand NameLONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X320MM 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
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12421434
MDR Text Key269763853
Report Number0009610622-2021-00677
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3525-1320S
Device Catalogue Number35251320S
Device Lot NumberK0C8874
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
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: 09/03/2021 Patient Sequence Number: 1
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