MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482802745

Device Problem Fracture (1260)

Patient Problems Pain (1994); Injury (2348); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2018

Event Type  Injury  

Event Description

Patient experienced pain some time after surgery.A screw which had been implanted had fractured.There was no issue with the original procedure, and there has not been a revision surgery.

Event Description

Patient experienced pain some time after surgery.A screw which had been implanted had fractured.There was no issue with the original procedure, and there has not been a revision surgery.A further information received from the sales rep on 01/30/2019 (pr id: (b)(4)), the patient was revised to remove the screw and fixation extension.The tip of the broken screw was left in the patient body.

Manufacturer Narrative

Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via visual inspection.The tip was not returned as it still implanted in the patient as it could not be removed during the revision surgery.Per email correspondence, there were no complications during the initial surgery.The surgical technique states that 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.Conclusion: tip not able to be retrieved from the patient during revision surgery indicate that the patient might have hard bone quality.It is also possible that screw hole was not prepared adequately, screw trajectory was incorrect or it was driven too deep inside the bone.High level post-op activity and unstable construct can also contribute to the event.However, the exact root cause could not be determined.

Event Description

Patient experienced pain some time after surgery.A screw which had been implanted had fractured.There was no issue with the original procedure, and there has not been a revision surgery.A further information received from the sales rep on 01/30/2019 (pr id: 2001113), the patient was revised to remove the screw and fixation extension.The tip of the broken screw was left in the patient body.

Manufacturer Narrative

Reportable event type: updated to serious injury.

Manufacturer Narrative

Method: nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via email correspondence with the sales rep.No device was returned (still implanted) and lot# was not provided.Therefore, device evaluation, complaint history review could not be performed.Conclusion: based on the information available, the exact root cause could not be determined.Device still implanted in the patient.

Event Description

Patient experienced pain some time after surgery.A screw which had been implanted had fractured.There was no issue with the original procedure, and there has not been a revision surgery.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8109693
• MDR Text Key: 128722089
• Report Number: 0009617544-2018-00276
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: 07613327002010
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482802745
• Device Lot Number: 169828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1