MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X50MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482802750
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a primary surgery was performed for purulent spondylitis on (b)(6) 2016.The symptoms cured, the extraction surgery was performed on (b)(6) 2016.During surgery, the surgeon noticed that the s1 left screw has broken.The tip of the screw could not be removed and was remained to the patient.Update as per additional information, the extraction surgery was not due to the fractured screw, fractured screw was identified during the extraction surgery.The patient had fused.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the threaded body of the screw was confirmed to be fractured.Upon manufacturing history review, no relevant issues found.Conclusion: the possible root cause of the reported event is fatigue.
Event or Problem Description
It was reported that a primary surgery was performed for purulent spondylitis on (b)(6) 2016.The symptoms cured, the extraction surgery was performed on (b)(6) 2016.During surgery, the surgeon noticed that the s1 left screw has broken.The tip of the screw could not be removed and was remained to the patient.As per additional information, the extraction surgery was not due to the fractured screw, fractured screw was identified during the extraction surgery.The patient had fused.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X50MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6254584
• Report Number: 0009617544-2017-00015
• Device Sequence Number: 89756
• Product Code: NKB
• UDI-Device Identifier: 07613327002027
• UDI-Public: (01)07613327002027
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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 Catalogue Number: 482802750
• Device Lot Number: 156269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 60