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

Model Number	482804645
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that revision surgery was performed to remove an es2 screw that had migrated and was now causing the patient pain.During the revision surgery, while the surgeon was removing a different screw, the screw appeared to have fractured.Upon review of the pre-operative x-ray, the surgeon noticed that the other es2 screw had fractured before the revision surgery.Both screws were removed.This report captures the migrated screw.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog and no adverse trends were observed.The date of initial surgery is unknown.Revision surgery was performed on (b)(6) 2021.Patient's detail including activity level and bone quality are unknown.Operative notes and x-rays were not provided.Due to lack of information and device not returned, an exact cause of the migration of screw cannot be determined.Potential causes include: inadequate initial construct/ excess torque applied on the construct, poor bone quality of patient, patient non-fusion, high activity level, patient fall, etc.Status and location of the device is unknown.

• 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
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13315323
• Report Number: 0009617544-2022-00005
• Device Sequence Number: 1701408
• Product Code: NKB
• UDI-Device Identifier: 07613327002188
• UDI-Public: 07613327002188
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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: 482804645
• Device Catalogue Number: 482804645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown