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.
Additional Manufacturer Narrative
The sales rep reported event of a was confirmed via correspondence with sales rep.The device was not returned, therefore visual, dimensional, functional analysis could not be performed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The surgical technique states "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.Delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) should be revised or removed immediately before serious injury occurs." 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.
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.

• 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: 7560531
• Report Number: 0009617544-2018-00123
• Device Sequence Number: 11092339
• 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
• Report Date (Section B): 11/20/2018

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
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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