MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 40; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48145540
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; rod slipped out of screw.
Additional Manufacturer Narrative
Method: risk assessment; results: visual, analysis, device history and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the plausible root cause of the event was determined to be user error.
Event or Problem Description
It was reported that; rod slipped out of screw.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 40
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6089748
• Report Number: 0009617544-2016-00447
• Device Sequence Number: 1136235
• Product Code: NKB
• UDI-Device Identifier: 04546540450180
• UDI-Public: (01)04546540450180
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• 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): 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: 48145540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• 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
• Patient Age: 8 MO