MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 8.5X55MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482804855
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that screw head had come off the screw post-operatively as a result of a patient fall.The patient was revised to replace the screw.
Additional Manufacturer Narrative
Method: x-ray, labelling review, and risk assessment.Visual inspection: screw was returned with disengaged tulip head.Deformation was observed on tulip head locking ring and on the head of screw shank.Functional inspection: could not be performed because the device was confirmed to be damaged during visual inspection.Dimensional inspection: not performed because there is no indication the event was related to dimensions of the device.Material analysis: material analysis was not performed as there is no indication the event was related to the material properties of the device.Device history records were reviewed and no relevant manufacturing issues were identified as all units met stryker specifications.It was confirmed via x-ray and visual inspection that the screw tulip disengaged post-operatively.It was reported that there were no complications during the initial surgery.Deformation of tulip head locking ring indicates that the screw shaft was pressing against deformed side of the tulip head likely due to over angulation on screw.Deformation on the screw shank also indicate over-angulation of the screw.Root cause of the reported event was determined to be patient fall and over angulation on screw.From surgical technique: the surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.
Event or Problem Description
It was reported that the head of the screw broke off as a result of a patient fall.The patient was revised (b)(6) 2019 to replace the screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 8.5X55MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8420137
• Report Number: 0009617544-2019-00023
• Device Sequence Number: 18901405
• Product Code: NKB
• UDI-Device Identifier: 07613327002485
• UDI-Public: 07613327002485
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 482804855
• Device Lot Number: 164456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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: 48 YR
• Patient Weight: 70