MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	482802640
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the posterior fixation from l2 to s was done at (b)(6).At (b)(6), the screw head was came off from the screw was confirmed at ct.However, the patient had no symptoms and the revision was not done.The part of the complaint was l3 or l4.
Additional Manufacturer Narrative
Method: risk assessment.Result: the reported event was confirmed via email correspondence with the sales representative and ct imaging.The ct image shows tulip head of one of the screws disengaged.The tulip head of another screw in the image remain intact with the shaft.The product is still implanted, and lot number was not provided.Therefore device inspection and device history review could not be performed.The root cause of this reported event could not be determined conclusively.
Event or Problem Description
It was reported that the posterior fixation from l2 to s was done at (b(6).At (b)(6), the screw head was came off from the screw was confirmed at ct.However, the patient had no symptoms and the revision was not done.The part of the complaint was l3 or l4.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7163339
• Report Number: 0009617544-2018-00002
• Device Sequence Number: 13887347
• Product Code: KWP
• UDI-Device Identifier: 07613327001938
• UDI-Public: (01)07613327001938
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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: 482802640
• Device Catalogue Number: 482802640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR