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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; IMPLANT-CROSS CONNECTOR
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STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; IMPLANT-CROSS CONNECTOR Back to Search Results
Catalog Number 48902015
Device Problems Difficult to Remove (1528); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2014
Event Type  malfunction  
Event Description
It was reported that during demonstration, when the sales rep tried to loosen the set screw of connector, it was worn.As a result, the connector, rod, screw and connector adapter could not be detached.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the trio trauma offset connector small was confirmed to have a jammed set screw via visual inspection.The hex bores on the set screw was severely stripped and thus it is jammed in a manner that locks the rod in place and cannot be disassembled.There were no manufacturing issues pertaining to this lot number.The communication log indicates that this product was used often for demonstration purposes.Conclusion: the likely cause of this event is that the set screw bore became worn over time until the set screw was stripped in the engaged position, thus it cannot be backed out.
 
Event Description
It was reported that during demonstration, when the sales rep tried to loosen the set screw of connector, it was worn.As a result, the connector, rod, screw and connector adapter could not be detached.
 
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Brand Name
TRIO LX SMALL CONNECTOR
Type of Device
IMPLANT-CROSS CONNECTOR
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 Key3637202
MDR Text Key3986255
Report Number0009617544-2014-00073
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeJA
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 01/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48902015
Device Lot Number126734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/24/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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