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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE PRODUCT
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STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE PRODUCT Back to Search Results
Catalog Number UNK_SPN
Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2017
Event Type  malfunction  
Event Description
It was reported that; surgeon placed pedicle screw bilaterally t8 t9 t10, did a decompression went in to place rods, at the right side.Sized appropriate rod, put 3 set screws one at 3 levels provisionally tightened.Surgeon the used counter torque and audible torque wrench.Final tightened each blocker to 8nm and the torque wrench appeared to be functioning properly, the lines matched up at 8nm and also clicked.Switched to the left side, sized the rod, provisionally tightened the blockers and started with left t10 counter torque wrench and final tightened with the audible torque wrench.When the surgeon tightened the screw head splayed and a pop was heard.The torque wrench did not indicate 8nm nor did it have any audible notification.The blocker was removed and the screw was placed with a new screw in left t10 with a new blocker.Attempted to put rod and new blocker on and attempted to final tightened with the audible torque wrench and had the same result.There was no audible recognition, and the lines did not move or merry at all.A back up torque wrench was used to successfully complete the surgery, other 2 screws were final tightened successfully and the patient was bone grafted and closed.
 
Manufacturer Narrative
Method: risk assessment; result: no device was returned, and no catalog or lot number was reported.Device inspection as well as device history and complaint review could not be completed.Conclusion: the root cause is excessive torque applied due to a jammed torque wrench.
 
Event Description
It was reported that; surgeon placed pedicle screw bilaterally t8 t9 t10, did a decompression went in to place rods, at the right side.Sized appropriate rod, put 3 set screws one at 3 levels provisionally tightened.Surgeon the used counter torque and audible torque wrench.Final tightened each blocker to 8nm and the torque wrench appeared to be functioning properly, the lines matched up at 8nm and also clicked.Switched to the left side, sized the rod, provisionally tightened the blockers and started with left t10 counter torque wrench and final tightened with the audible torque wrench.When the surgeon tightened the screw head splayed and a pop was heard.The torque wrench did not indicate 8nm nor did it have any audible notification.The blocker was removed and the screw was placed with a new screw in left t10 with a new blocker.Attempted to put rod and new blocker on and attempted to final tightened with the audible torque wrench and had the same result.There was no audible recognition, and the lines did not move or merry at all.A back up torque wrench was used to successfully complete the surgery, other 2 screws were final tightened successfully and the patient was bone grafted and closed.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
UNKNOWN SPINE PRODUCT
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR   33610
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6461142
MDR Text Key72113828
Report Number0009617544-2017-00132
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
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 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_SPN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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