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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TAYLOR GROVE KLS MARTIN LP KLS 2.0X13MM SCREW; PLATE, BONE
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TAYLOR GROVE KLS MARTIN LP KLS 2.0X13MM SCREW; PLATE, BONE Back to Search Results
Model Number 25-872-13-91
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
Event Type  Injury  
Event Description
Surgeon was performing a very complicated orif of mandibular fractures.Many screws and plates were inserted and removed trying to find the proper fusion for this patient.One of the screw heads broke off, but the threading remained in the patient¿s mandible.The screw was a kls 2.0x13mm screw with reference number: 25-872-13-91.The doctor was satisfied with the fixation that it provided and decided that it would cause more harm trying to retrieve it, than for it to remain.The screw head was retrieved from the mouth and placed in the sharps container.Both the surgeon and scrub tech confirmed that it was out of the patient.Taylor grove-kls rep told the manager of quality that he was going to report the broken screw to the company.Fda safety report id # (b)(4).
 
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Brand Name
KLS 2.0X13MM SCREW
Type of Device
PLATE, BONE
Manufacturer (Section D)
TAYLOR GROVE KLS MARTIN LP
MDR Report Key9676947
MDR Text Key178140226
Report NumberMW5092801
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-872-13-91
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age29 YR
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