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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 Ø5X37,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965037S
Health Effect - Clinical Code Pain (1994)
Date of Event 11/01/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
 
Event or Problem Description
On (b)(6) 2015, the patient underwent the surgery with the g3 nail and u-lag screw.After surgery, the patient felt the pain.The surgeon confirmed x-ray.And he found that the fracture part was non-union.Therefore, the patient underwent the revision surgery by the bone graft and the distal screw remove on (b)(6) 2016.
 
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Brand Name
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key6133814
Report Number0009610622-2016-00589
Device Sequence Number13491113
Product Code HSB
UDI-Device Identifier04546540382337
UDI-Public04546540382337
Combination Product (Y/N)N
PMA/510(K) Number
K003018
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date01/31/2020
Device Catalogue Number18965037S
Device Lot NumberK0A64E0
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/01/2016
Initial Report FDA Received Date11/29/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age84 YR
Patient Weight42
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