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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA TRAUMACEM V+ CEMENT KIT 10 ML
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SYNTHES USA TRAUMACEM V+ CEMENT KIT 10 ML Back to Search Results
Catalog Number 07.702.040S
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2013
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during an augmentation of the pfna (proximal femoral nail anti-rotation) nail, a small amount of pmma (polymethylmethacrylate) has leaked into the joint.The previous inspection with contrast medium showed no perforation of the joint surface.During the procedure, it was decided to leave the cement.Patient is included in the (b)(4) study and is followed up regularly.This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Placeholder.
 
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Brand Name
TRAUMACEM V+ CEMENT KIT 10 ML
Manufacturer (Section D)
SYNTHES USA
west chester PA 1938 0
Manufacturer Contact
mary haber
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key3547873
MDR Text Key17263771
Report Number2520274-2013-07933
Device Sequence Number1
Product Code MQV
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/05/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.702.040S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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