MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	482802745
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tlif surgery, the surgeon felt idle of torque wrench when performing a final tightening of the screw of s1 segment.The screw head was deviated from the screw shaft when it was extracted.The screw was replaced with other new one and the surgery was completed.
Additional Manufacturer Narrative
Lot# 160691.No relevant manufacturing issues were identified as all units met stryker specifications.Visual and functional inspection could not be performed because the device was not returned.Without the device evaluation, the exact root cause cannot be determined.
Event or Problem Description
It was reported that during tlif surgery, the surgeon felt idle of torque wrench when performing a final tightening of the screw of s1 segment.The screw head was deviated from the screw shaft when it was extracted.The screw was replaced with other new one and the surgery was completed.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6814986
• Report Number: 0009617544-2017-00333
• Device Sequence Number: 16524400
• Product Code: KWP
• UDI-Device Identifier: 07613327002010
• UDI-Public: (01)07613327002010
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 482802745
• Device Catalogue Number: 482802745
• Device Lot Number: 160691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR