MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48135104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a xia titanium connector fractured post-operatively.The patient has been revised.
Additional Manufacturer Narrative
Visual inspection: visual inspection confirmed that the returned cross connector was fractured.Material analysis: the analysis confirmed that the connector experienced fatigue fracture.No material or manufacturing defects were observed on the surfaces examined.A review of the device history was performed and there were no relevant manufacturing issues identified as all units met stryker specifications.A review of the complaint history records was performed and there were no similar complaints identified.Per surgical technique: extended connectors are used to facilitate distraction between two adjacent rods therefore restoring spinal segment height.When using an extended connector, the uncut ends of the rod should be inserted into the connector.Also, it is important to keep the rods straight along the length of the extended connector for proper insertion.Once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidate.Most probable cause of the reported event was determined to be fatigue on construct over time.
Event or Problem Description
It was reported that a xia titanium connector fractured post-operatively.The patient has been revised.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR LARGE
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9548027
• Report Number: 0009617544-2020-00006
• Device Sequence Number: 11356641
• Product Code: NKB
• UDI-Device Identifier: 04546540449597
• UDI-Public: 04546540449597
• Combination Product (Y/N): N
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 48135104
• Device Catalogue Number: 48135104
• Device Lot Number: 13C429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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