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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. CORTICAL LOCKING SCREW 3.5 MM X 12 MM

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SKELETAL DYNAMICS INC. CORTICAL LOCKING SCREW 3.5 MM X 12 MM Back to Search Results
Model Number CORTICAL LOCKING SCREW
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/09/2017
Event Type  malfunction  
Event Description
Patient underwent a right wrist open reduction and internal fixation procedure. During surgery, a plate was pinned into position under fluoroscopy. The surgeon was using screws to secure the plate into the pt's bone. He used 2 locking screws proximally but while screwing in the 2nd one on the head of the screw broke off before it had been completely screwed in. As most of the screw was embedded in the bone there was no way the surgeon could remove it without removing the plate and further disrupting the fracture. The decision was made to leave the screw in place as it was unlikely to come out of the bone as it was in deep enough before the head broke off.
 
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Brand NameCORTICAL LOCKING SCREW 3.5 MM X 12 MM
Type of DeviceCORTICAL LOCKING SCREW
Manufacturer (Section D)
SKELETAL DYNAMICS INC.
miami FL 33176
MDR Report Key6249061
MDR Text Key65028880
Report NumberMW5067194
Device Sequence Number1
Product Code HSB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCORTICAL LOCKING SCREW
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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