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

Catalog Number	486614110
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: RADIUS CROSS CONNECTOR VARIABLE MEDIUM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6234299
• Report Number: 0009617544-2017-00008
• Device Sequence Number: 16249855
• Product Code: NKB
• UDI-Device Identifier: 04546540546173
• UDI-Public: (01)04546540546173
• Combination Product (Y/N): N
• PMA/510(K) Number: K062270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 486614110
• Device Lot Number: 157443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1