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

Model Number	486614110
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when the set screws on both sides of the cross connector variable were fixed finally, the integrated set screw was disengaged.Another cross connector was used and complete the procedure.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met specifications.The device was inspected and one of the set screws was found disengaged.The most likely cause of the reported event was determined to be user overloading.
Event or Problem Description
It was reported that; when the set screws on both sides of the cross connector variable were fixed finally, the integrated set screw was disengaged.Another cross connector was used and complete the procedure.

• 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: 6567278
• Report Number: 0009617544-2017-00199
• Device Sequence Number: 613042
• Product Code: NKB
• UDI-Device Identifier: 04546540546173
• UDI-Public: (01)04546540546173(11)161221(10)16E293
• Combination Product (Y/N): N
• PMA/510(K) Number: K062270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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 Model Number: 486614110
• Device Catalogue Number: 486614110
• Device Lot Number: 16E293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1