MAUDE Adverse Event Report: STRYKER SPINE-US XIA ROD DIA. 6 X 480; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	03802480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rod broke post-operatively.The medical intervention required to remove the screw and rod.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence with the site.The device was not returned as it would not be released by the hospital, thus inspection could not be performed.The lot number is unknown, so manufacturing review could not be completed.The ifu lists out various adverse effects and situations that could cause post op fractures, including strenuous activity or trauma, smoking, degenerative disease, obesity, implant selection, construct design, and non-union.The ifu states specifically that " the surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.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." conclusion: based on the information provided, a definite root cause cannot be determined, but possible root causes include the reasons listed in the ifu above as well as patient bone quality, excessive torque during final tightening, improper rod contouring, too much residual stress on the rod from bending/ tightening/ rotating, and under tightened blockers.Device not returned.
Event or Problem Description
It was reported that the rod broke post-operatively.The medical intervention required to remove the screw and rod.

• Brand Name: XIA ROD DIA. 6 X 480
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8061435
• Report Number: 3005525032-2018-00070
• Device Sequence Number: 11360114
• Product Code: KWP
• UDI-Device Identifier: 04546540147905
• UDI-Public: 04546540147905
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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 Catalogue Number: 03802480
• Device Lot Number: UNKNOW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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