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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA; POLYMETHYLMETHACRYLATE BONE CEMENT
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SYNTHES USA; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Date 10/15/2013
Event Type  malfunction  
Event Description
During a review of general sales force feedback and cadaver lab meeting minutes, it was reported that the synflate vertebral balloon is difficult to get down in the synflate cannula.It feels 'sticky' and does not insert smoothly.This complaint is not related to a specific surgery.This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional product code: nrx.Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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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Type of Device
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key4565165
MDR Text Key17592933
Report Number2520274-2015-11398
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK130146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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