MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 5.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem Description
A physician has reported that a patient has undergone revision surgery to address five migrated es2 screws, approximately two-months after implantation.This record captures the third of five screws.
Event or Problem Description
A physician has reported that a patient has undergone revision surgery to address five migrated es2 screws, approximately two-months after implantation.This record captures the third of five screws.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of the complaint and device history records could not be performed as a valid lot number was not provided and could not be obtained.Per es2 surgical technique was reviewed: the surgeon must warn the patient of the surgical risks and made aware of possible adverse effects.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.Patients who smoke have been shown to have an increased incidence of non-unions.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.Due to lack of information and device not returned, cause of the event could not be determined.Potential causes include: incorrect device placement, poor fixation construct, poor patient bone quality, excessive patient post-op activities beyond surgeon recommendation, patient fall, etc.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 5.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10752346
• Report Number: 0009617544-2020-00182
• Device Sequence Number: 11609348
• Product Code: NKB
• UDI-Device Identifier: 07613327001884
• UDI-Public: 07613327001884
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 482802540
• Device Catalogue Number: 482802540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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