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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS CROSS CONNECTOR VARIABLE MEDIUM PEDICLE SCREW SPINAL SYSTEM

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STRYKER SPINE-FRANCE RADIUS CROSS CONNECTOR VARIABLE MEDIUM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 486614110
Device Problems Break (1069); Difficult to Insert (1316); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2016
Event Type  malfunction  
Event Description
It was reported that; during surgery (l5/s tlif), the screw of the connector broke when the surgeon striked the screw because it was difficult to fit the connector to the rod. The surgeon used other connector and finished the surgery.
 
Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment. Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified. The most likely cause of the reported event was determined to be the applied overloading while the surgeon hit the connector.
 
Event Description
It was reported that; during surgery (l5/s tlif), the screw of the connector broke when the surgeon striked the screw because it was difficult to fit the connector to the rod. The surgeon used other connector and finished the surgery.
 
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Brand NameRADIUS CROSS CONNECTOR VARIABLE MEDIUM
Type of DevicePEDICLE 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
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6234299
MDR Text Key64587129
Report Number0009617544-2017-00008
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
Type of Report Initial,Followup
Report Date 03/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number486614110
Device Lot Number157443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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