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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 7.5 X 50MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 7.5 X 50MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Catalog Number 03829755
Device Problems Difficult to Remove (1528); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2014
Event Type  malfunction  
Event Description
It was reported that the surgeon implanted a 6.5x55 reduction screw in l4.Upon review of placement using oarm/stealth the screw was lateral.Upon removing screw the tulip was locked at angle to the bone screw, making it hard to remove.They opted for a shorter screw, and just used a regular poly axial.
 
Manufacturer Narrative
Method: device not returned; results: the device was discarded by the hospital, so no sample is available for evaluation.Because no device was received back for evaluation, testing and inspections could not be performed to aid in root cause analysis.However, it should be noted that these devices, if over torqued enough will deform, causing loss of polyaxility.These devices are meant for one time use and reusing devices is advised against in the surgical technique.Conclusion: with no device available for evaluation, the root cause of the customer reported event could not be determined conclusively.
 
Event Description
It was reported that the surgeon implanted a 6.5x55 reduction screw in l4.Upon review of placement using oarm/stealth the screw was lateral.Upon removing screw the tulip was locked at angle to the bone screw, making it hard to remove.They opted for a shorter screw, and just used a regular polyaxial.
 
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Brand Name
XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 7.5 X 50MM
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 Key4366913
MDR Text Key5233542
Report Number0009617544-2014-00543
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061854
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 12/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03829755
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2014
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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