MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 45; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48146545
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon was threading a distraction screw post into the head of the screw in order to utilize distraction retractor and the head of the screw disengaged from the threading.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Visual inspection showed the device was returned in two pieces.The tulip head was disengaged from the main screw body.No relevant manufacturing issues were identified as all units met specifications.The plausible root cause of the reported event cannot be identified conclusively.
Event or Problem Description
It was reported that; surgeon was threading a distraction screw post into the head of the screw in order to utilize distraction retractor and the head of the screw disengaged from the threading.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 45
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6419379
• Report Number: 0009617544-2017-00101
• Device Sequence Number: 550419
• Product Code: NKB
• UDI-Device Identifier: 04546540450272
• UDI-Public: (01)04546540450272
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• 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): 05/24/2017

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: 48146545
• Device Lot Number: 166330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1