MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM MULTIAXIAL CROSSLINK 53MM 73MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48236053
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A plif surgery on (b)(6) 2010 resulted in an adjacent vertebral disorder.As a result, revision surgery was conducted on (b)(6) 2018 during which the nut on the crosslink broke while tightening it with the nut driver.The surgery was completed successfully with an alternate crosslink.No adverse consequences to the patient were reported during revision surgery.
Event or Problem Description
A plif surgery on (b)(6) 2010 resulted in an adjacent vertebral disorder.As a result, revision surgery was conducted on (b)(6) 2018 during which the nut on the crosslink broke while tightening it with the nut driver.The surgery was completed successfully with an alternate crosslink.No adverse consequences to the patient were reported during revision surgery.
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.The connector was returned disassembled.The center locking nut was found to be fractured in 2 pieces, with the end cap fractured off of the main nut.Device was submitted for material analysis and found to have fractured in a ductile overload mode.The elemental constituents were consistent with the print.No material or manufacturing defects were found.It was reported that the center nut fractured while it was being tightened with the mac nut driver.It was reported that it was at a high angle and the surgeon most likely overtightened the center nut.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.All fragments were retrieved.Conclusion: material analysis of the device found that the center nut fractured in ductile overload mode which is consistent with overtightening of the device.The most likely root cause is overtightening of the center nut causing it to fracture.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 53MM 73MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7644313
• Report Number: 0009617544-2018-00149
• Device Sequence Number: 1550192
• Product Code: NKB
• UDI-Device Identifier: 04546540560889
• UDI-Public: (01)04546540560889
• 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 Model Number: 48236053
• Device Catalogue Number: 48236053
• Device Lot Number: 167205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 06/27/2018
• 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