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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-LEFT APPLIANCE FIXATION NAIL
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SYNTHES USA 4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-LEFT APPLIANCE FIXATION NAIL Back to Search Results
Catalog Number 02.001.304
Device Problem Break (1069)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision surgery for a distal femur fracture. The broken plate was taken out along with the screws which were all intact. A new plate with new screws was implanted. There was no time delay and the surgery was successfully completed. The patient outcome was reported as good. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Date of original implant is unknown. It is unknown whether or not the facility will be returning the complainant part. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name4.5MM LCP® CURVED CONDYLAR PLATE 14 HOLES/314MM-LEFT
Type of DeviceAPPLIANCE FIXATION NAIL
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key4381169
MDR Text Key5240580
Report Number2520274-2015-10053
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK041911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.001.304
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/05/2015 Patient Sequence Number: 1
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