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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA T-PAL LARGE TRIAL IMPLANT SIZ 12; TEMPLATE
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SYNTHES USA T-PAL LARGE TRIAL IMPLANT SIZ 12; TEMPLATE Back to Search Results
Catalog Number 03.812.212
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2014
Event Type  malfunction  
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a cage insertion the implant holder of t-pal stuck in the implant itself and was not easy to remove.After tightening the implant holder and releasing the implants afterwards, the cage could be normally detached.This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.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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Brand Name
T-PAL LARGE TRIAL IMPLANT SIZ 12
Type of Device
TEMPLATE
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 Key4297248
MDR Text Key5270203
Report Number2520274-2014-15072
Device Sequence Number1
Product Code HWT
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.812.212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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