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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA
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SYNTHES USA Back to Search Results
Device Problems Difficult to Remove (1528); Separation Failure (2547)
Patient Problem No Code Available (3191)
Event Date 12/17/2013
Event Type  malfunction  
Event Description
Synthes (b)(4) sales consultant reported the following event occurred during a l5-s1 instrumented fusion with t-pal tplif (transforaminal posterior lumbar interbody fusion).After placement of the t-pal spacer, the surgeon had difficulty disengaging the t-pal applicator inner shaft (03.812.003) from the t-pal spacer.Surgeon removed the trial applicator handle (03.812.001) and eventually was able to remove the inner shaft from the spacer.Surgeon successfully completed the procedure.There was reportedly some surgical delay for an unknown amount of time.This report is for an unknown spacer.This is 2 of 2 report for complaint (b)(4).
 
Manufacturer Narrative
Device is used for treatment, not diagnosis.Device is an unknown t-pal spacer, quantity 1.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.
 
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Manufacturer (Section D)
SYNTHES USA
west chester PA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key3652479
MDR Text Key4201339
Report Number2520274-2014-00917
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K100089
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 12/17/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Yes
Initial Date Manufacturer Received 12/17/2013
Initial Date FDA Received02/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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