MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482316540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that during a revision surgery a screw broke.The broken screw was left inside the patient.Revision surgery was performed due to patient factor: adjacent intervertebral disorders, extension was performed on l2 to s1.No adverse consequences has been reported due to screw breakage.
Event or Problem Description
It is reported that during a revision surgery a screw broke.The broken screw was left inside the patient.Revision surgery was performed due to patient factor: adjacent intervertebral disorders, extension was performed on l2 to s1.No adverse consequences has been reported due to screw breakage.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, product history review, complaint history review, labelling review, risk assessment.Result: the customer reported event was confirmed via visual inspection and x ray.The returned screw was fractured at the screw shank.The fractured piece was not returned.Device was sent for material analysis.The fractured screw was visually consistent with a fatigue fracture.The fracture surface was too damaged post fracture to determine the exact mode.The elemental constituents were consistent with the print.No material or manufacturing defects were found.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported that the screw was implanted in (b)(6) 2015.According to the ifu, "while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred." conclusion: the most likely root cause is fatigue fracture due to length of implantation.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7572788
• Report Number: 0009617544-2018-00135
• Device Sequence Number: 14044505
• Product Code: OSH
• UDI-Device Identifier: 04546540562234
• UDI-Public: 04546540562234
• Combination Product (Y/N): N
• 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): 09/05/2018

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: 482316540
• Device Lot Number: B53478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1