MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	482802645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the extraction surgery was performed due to healing of the disease.During the extraction surgery, the breakage of l5 right side screw was found.The tip of the screw was remained to the patient and the surgery was finished.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The returned screw was inspected and it was confirmed to be fractured.Conclusion: the plausible root cause of the event is high activity of the patient leading to stress on the implant causing fracture.
Event or Problem Description
It was reported that; the extraction surgery was performed due to healing of the disease.During the extraction surgery, the breakage of l5 right side screw was found.The tip of the screw was remained to the patient and the surgery was finished.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6518666
• Report Number: 0009617544-2017-00167
• Device Sequence Number: 13785772
• Product Code: NKB
• UDI-Device Identifier: 07613327001945
• UDI-Public: (01)07613327001945
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 482802645
• Device Catalogue Number: 482802645
• Device Lot Number: 153180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR