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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS CROSS CONNECTOR 30MM; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-FRANCE RADIUS CROSS CONNECTOR 30MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 486614030
Device Problems Break (1069); Fracture (1260); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2015
Event Type  malfunction  
Event Description
It was reported that; during surgery (l2-s fixation), when surgeon tightened locking plug of the cross connector 28 mm, abnormal noise occurred and the arm portion was broken.After that two cross connector 30 mm were broken during bending using bender.
 
Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause is excessive bending of the cross connector which resulted in the fracture.
 
Event Description
It was reported that; during surgery (l2-s fixation), when surgeon tightened locking plug of the cross connector 28 mm, abnormal noise occurred and the arm portion was broken.After that two cross connector 30 mm were broken during bending using bender.
 
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Brand Name
RADIUS CROSS CONNECTOR 30MM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
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
linford leitch
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5305534
MDR Text Key34575370
Report Number0009617544-2015-00540
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K062270
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 11/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number486614030
Device Lot Number133902
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2013
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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