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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; SPINAL INTERLAMINAL FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Catalog Number 48902015
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2014
Event Type  malfunction  
Event Description
It was reported that during trio trauma surgery (t11-l1 were fixed, t12 were skipped), when the surgeon tried to remove the connector adapter from the connector after final tightening, one of the connector adapter could not be removed (t11 right side).The surgeon loosened right side connectors, removed rod and exchanged the relevant connector adapter and connector.There was 20 minutes delay in the surgery.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the connector was received with a jammed set screw with visibly worn hex corners.The worn nature of the hex suggests that the corresponding hex tip was forcibly rotated while the set screw remained stationary, which confirms that the set screw was jammed in the offset connector.Furthermore, the screw was attempted to be loosened, but could not be.Conclusion: the jamming occurred due to galling of the connector and biological particles lodged between the offset connector and set screw threads.Therefore the related connector was implanted in the body for some time; it is highly likely that the jamming is due to these causes.
 
Event Description
It was reported that during trio trauma surgery (t11-l1 were fixed, t12 were skipped), when the surgeon tried to remove the connector adapter from the connector after final tightening, one of the connector adapter could not be removed (t11 right side).The surgeon loosened right side connectors, removed rod and exchanged the relevant connector adapter and connector.There was 20 minutes delay in the surgery.
 
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Brand Name
TRIO LX SMALL CONNECTOR
Type of Device
SPINAL INTERLAMINAL FIXATION ORTHOSIS
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
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key4354169
MDR Text Key5202054
Report Number0009617544-2014-00528
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48902015
Device Lot Number13F604
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2013
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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