MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48232600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was fixed from around t10 to the iliac bone.Post operatively, two rods broke on both sides near the iliac screw.Revision surgery was performed to remove the broken rods.Additional actions performed during revision: loosen the screw of s1 and replace to 1mm thick screw and fix it to the caudal side of the iliac connector with 4 rods.
Event or Problem Description
It was reported that a patient was fixed from around t10 to the iliac bone.Post operatively, two rods broke on both sides near the iliac screw.Revision surgery was performed to remove the broken rods.Additional actions performed during revision: loosen the screw of s1 and replace to 1mm thick screw and fix it to the caudal side of the iliac connector with 4 rods.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, product history review, labelling review, risk assessment.Results: the rod fragment that was returned was confirmed via visual inspection to be fractured.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Material analysis on the returned rod was performed.The elemental constituents were consistent with a ti6al4v eli allow specified for titanium rods.No material or manufacturing defects were found.The rod was analyzed via sem and non-fractured and fractured end of the rod were compared.Conclusion: based upon analysis of returned products on previous complaints and material analysis on the returned rod, it is likely to have been fractured due to intra operative cutting prior to implantation.The probable root cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that a patient was fixed from around t10 to the iliac bone.Post operatively, two rods broke on both sides near the iliac screw.Revision surgery was performed to remove the broken rods.Additional actions performed during revision: loosen the screw of s1 and replace to 1mm thick screw and fix it to the caudal side of the iliac connector with 4 rods.
Additional Manufacturer Narrative
Correction: the complaint device was not returned as indicated in previous supplemental report 0009617544-2018-00122.Method: product history review, labelling review, risk assessment results: the reported event was confirmed via correspondence with sales rep.None of the rods were returned for evaluation.It is unknown whether the patient fused, experienced a fall or was involved in strenuous post-op activity.Information regarding the patient- bmi, bone quality is also unknown or how the issue was noticed- whether a scheduled visit or patient presented with pain.Conclusion: as it is unknown whether the patient fused, and the device was implanted for more than 2 years, the most likely root cause is fatigue fracture due to length of implantation.Bone quality and patient post op activity may have also contributed to the event.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7560532
• Report Number: 0009617544-2018-00122
• Device Sequence Number: 16533041
• Product Code: NKB
• UDI-Device Identifier: 04546540560582
• UDI-Public: (01)04546540560582
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2018

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: 48232600
• Device Catalogue Number: 48232600
• Device Lot Number: MME
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 10/05/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 09/27/2018; 10/31/2018
• 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