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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X360 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X360 MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18451036S
Device Problems Loss of or Failure to Bond (1068); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
 
Event Description
At (b)(6) 2017, the operation with t2 reconstruction nail was done for fracture of shaft of femur. After operation, the nonunion was confirmed. At (b)(6) 2018, nail fracture was confirmed. Medical history: collagen disease (take an steroids by mouth), diabetes, osteoporosis. Doctor's opinion: diabetes mellitus and progress of osteoporosis due to oral steroids for collagen diseases, and loading on the nail due to nonunion.
 
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Brand NameRECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X360 MM 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
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7245354
MDR Text Key99148485
Report Number0009610622-2018-00041
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K102992
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number18451036S
Device Lot NumberK0C9529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2016
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: 02/06/2018 Patient Sequence Number: 1
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