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	Failure of Implant (1924); Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during revision surgery (to treat adjacent intervertebral disorder), while removing the screw, the screw was found to be broken.The fractured screw was removed, and a new screw is inserted to successfully complete the procedure.No adverse consequences to the patient have been reported.
Event or Problem Description
It was reported that the during revision surgery (to treat adjacent intervertebral disorder), while removing the screw, the screw was found to be broken.The fractured screw was removed, and a new screw is inserted to successfully complete the procedure.No adverse consequences to the patient have been reported.
Additional Manufacturer Narrative
Method: labeling and risk assessment results: the customer reported an event of a polyaxial screw main body fracture post op which resulted in a no surgical delay or adverse consequences reported.It was reported that during a revision surgery for an adjacent vertebral disorder, while removing a screw, it was found to be broken.All fragments were reported to have been removed and a new screw was inserted in its place.The screw was returned to the patient and not available for evaluation.The lot number is unknown, so manufacturing review could not be completed.Conclusion: it was reported that the screw was initially inserted in (b)(6) 2015, meaning it was implanted for a period of almost 4 years.There were no reported complications in the original surgery, the patient did not fall, and operative notes/x rays are not available.It is unknown how the holes were prepared or what the patients¿ bone quality was.Since the device was not returned, a definite root cause cannot be determined, but it is likely the length of implantation, almost 4 years, contributed to the event.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.Bending, disassembly or fracture of any or all implant components.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred." additionally, "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." in patient possession.

• 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: 8431862
• Report Number: 0009617544-2019-00032
• Device Sequence Number: 11314095
• Product Code: NKB
• 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): 05/14/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482316540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0