MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 5.5 X 35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	488515535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that a tritanium pl cage and a xia ct polyaxial cortical screw, implanted at l5-s1, fractured post-operatively.Fusion was not achieved.Revision surgery will occur to replace devices.This report captures the screw.
Event or Problem Description
It was reported that a tritanium pl cage and a xia ct polyaxial cortical screw, implanted at l5-s1, fractured post-operatively.Fusion was not achieved.Revision surgery will occur to replace devices.This report captures the screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, provided x-ray shows the screw fractured at the shaft.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.From the xia 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.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." it was reported that the patient did not fuse after 1 year of implantation.According to the ifu, delayed union can lead to fatigue fracture.As the device was not returned, a definite root cause cannot be determined, but likely fractured in fatigue due to delayed union.

• Brand Name: POLYAXIAL CORTICAL SCREW 5.5 X 35
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10125323
• Report Number: 0009617544-2020-00080
• Device Sequence Number: 14069477
• Product Code: NKB
• UDI-Device Identifier: 07613327137347
• UDI-Public: 07613327137347
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: Health Professional
• Device Model Number: 488515535
• Device Catalogue Number: 488515535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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