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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO CONNECTOR ADAPTOR; INSTRUMENT-CONNECTOR ADAPTER
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STRYKER SPINE-FRANCE TRIO CONNECTOR ADAPTOR; INSTRUMENT-CONNECTOR ADAPTER Back to Search Results
Catalog Number 47113055
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2013
Event Type  malfunction  
Event Description
It was reported after a demonstration, the connector adapter could not be removed from the sample of offset connector.
 
Manufacturer Narrative
Results: the returned trio connector adaptor was identified as a concomitant product.The event was due to the trio lx small connector jamming which can be seen in mfr report # 0009617544-2014-00027.Conclusion: no failure was detected since the device is a concomitant product.
 
Event Description
It was reported after a demonstration, the connector adapter could not be removed from the sample of offset connector.
 
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Brand Name
TRIO CONNECTOR ADAPTOR
Type of Device
INSTRUMENT-CONNECTOR ADAPTER
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 3361 0
FR   33610
Manufacturer Contact
daniel roberts
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key3576110
MDR Text Key4141406
Report Number0009617544-2014-00024
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103292
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/19/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number47113055
Device Lot Number133836
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received12/19/2013
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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