MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X50MM; PEDICLE SCREW SPINAL SYSTEM.

Model Number	482802650
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017 implanted the procedure.On (b)(6) 2017 loosed four screws and dislodged the gage.On (b)(6) 2017, it was removed to new screw(other company) from four osing screws.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: no relevant manufacturing issues were found.Device inspection could not be performed, as the device was not returned.Conclusion: the root cause cannot be determined conclusively, as the device was not returned.
Event or Problem Description
It was reported that on (b)(6) 2017 implanted the procedure.(b)(6) 2017 loosed four screws and dislodged the gage.(b)(6) 2017, it was removed to new screw (other company) from four osing screws.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X50MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6578640
• Report Number: 0009617544-2017-00205
• Device Sequence Number: 16161827
• Product Code: NKB
• UDI-Device Identifier: 07613327001952
• UDI-Public: (01)07613327001952
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: No Information
• Device Model Number: 482802650
• Device Catalogue Number: 482802650
• Device Lot Number: 14G733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/18/2017
• 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