MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482804645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient is in possession of the device.
Event or Problem Description
Two screws were reported to have broken post-operatively.One screw was noted broken via x-ray and the other screw was noted broken during the revision surgery.It was reported that the right-side screw was replaced but that the left-side screw was not replaced because fusion had occurred.This record represents the left-side screw.
Additional Manufacturer Narrative
Corrected data: updated from 'adverse event and product problem' to 'product problem'.Updated from 'serious injury' to 'malfunction'.Visual, dimensional, functional and material analysis could not be performed as the device was not returned and remains implanted.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.Patient did not perform high level activities post op and did not experience a fall.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.Since fusion occurred, the implant has performed its intended function.As the device was not returned, root cause was not determined.Root cause of fracture may have been due to normal load overtime.
Event or Problem Description
Two screws were reported to have broken post-operatively.One screw was noted broken via x-ray and the other screw was noted broken during the revision surgery.It was reported that the right-side screw was replaced but that the left-side screw was not replaced because fusion had occurred.This record represents the left-side screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8707623
• Report Number: 0009617544-2019-00080
• Device Sequence Number: 13914576
• Product Code: NKB
• UDI-Device Identifier: 07613327002188
• UDI-Public: 07613327002188
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: Health Professional
• Device Catalogue Number: 482804645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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
• Patient Age: 55 YR
• Patient Weight: 54