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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH POWER MODULE FOR TRAUMA RECON SYSTEM
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SYNTHES GMBH POWER MODULE FOR TRAUMA RECON SYSTEM Back to Search Results
Catalog Number 05.001.202
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer reported the device gets hot.This is report 1 of 1 for complaint#(b)(4).
 
Manufacturer Narrative
Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr during pre-repair assessment performed by a technician, functional testing was performed and no failure was found.The device was sent back to the customer on (b)(4) 2013.Placeholder.
 
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Brand Name
POWER MODULE FOR TRAUMA RECON SYSTEM
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
ch-4436
oberdorf
SZ 
Manufacturer (Section G)
SYNTHES GMBH
eimattstrasse 3
ch-4436
oberdorf
SZ  
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key4145860
MDR Text Key4772630
Report Number8030965-2014-01245
Device Sequence Number1
Product Code MOQ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/19/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05.001.202
Device Lot Number2686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received06/19/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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