MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number	482315540
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; an incident of screw breakage in patients' body after surgery.Screw is found broken, then revision surgery is done, but the broken part cannot be retrieved (still in patient body).
Additional Manufacturer Narrative
Event or Problem Description
It was reported that; an incident of screw breakage in patients' body after surgery.Screw is found broken, then revision surgery is done, but the broken part cannot be retrieved (still in patient body).

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6904716
• Report Number: 0009617544-2017-00369
• Device Sequence Number: 483136
• Product Code: MNI
• UDI-Device Identifier: 04546540562043
• UDI-Public: (01)04546540562043
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K113666
• 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): 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 482315540
• Device Catalogue Number: 482315540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention