MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP MONOAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	03820645
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that patient underwent spinal surgery more than one year ago for lumbar spine injury (internal fixation.) it was reported that the patient recovered very well post operation.On (b)(6) 2019 when the doctor arranged to remove the plate, it was noticed via x-ray that a screw was fractured.Since the patient had no complaint of discomfort, the surgeon made the decision to leave the fractured screw implanted in the patient.
Event or Problem Description
It was reported that patient underwent spinal surgery more than one year ago for lumbar spine injury (internal fixation.) it was reported that the patient recovered very well post operation.On 12 mar 2019 when the doctor arranged to remove the plate, it was noticed via x-ray that a screw was fractured.Since the patient had no complaint of discomfort, the surgeon made the decision to leave the fractured screw implanted in the patient.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Complaint history records were not reviewed as a valid lot number was not provided and could not be obtained.Manufacturing history records were not reviewed as a valid lot number was not provided and could not be obtained.It was confirmed via x-ray provided that 1 screw was fractured at the shank.It was reported that the screw holes were prepared as per the surgical technique and implanted with the xia ii instrument.It was not a difficult angle, normal force was used, and there were no complications during the initial surgery.The patient has normal activity patterns, no reports of falls, and normal bone quality.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.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.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 the device was not returned, a definitive root cause could not be determined, however, it is likely that the length of implantation (over 1 year) contributed to the event.Non fusion can cause the implant to be subjected to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.If the patient fused, these devices serve no functional purpose and can be removed.

• Brand Name: XIA LP MONOAXIAL SCREW 6.5 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8718990
• Report Number: 3005525032-2019-00048
• Device Sequence Number: 2003651
• Product Code: NKB
• UDI-Device Identifier: 04546540148919
• UDI-Public: 04546540148919
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• 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): 07/25/2019

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: Health Professional
• Device Catalogue Number: 03820645
• Device Lot Number: B72822
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1