MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48236043
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the center screw of the crosslink broke when the surgeon fasten it.
Additional Manufacturer Narrative
Visual inspection showed the crosslink set screw fractured.The visual inspection of the device suggest that there was over tightening, this could result in additional stress on the implant lead to ductile over load fracture of the implant.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The plausible root cause of the event is determined to be over torqeuing of the set screw leading to fracture.
Event or Problem Description
It was reported that during surgery, the center screw of the crosslink broke when the surgeon fasten it.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6954347
• Report Number: 0009617544-2017-00375
• Device Sequence Number: 10933413
• Product Code: MNH
• UDI-Device Identifier: 04546540560872
• UDI-Public: (01)04546540560872
• Combination Product (Y/N): N
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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: 48236043
• Device Catalogue Number: 48236043
• Device Lot Number: 161632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR