MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE L 7.5X50MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	482804750
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Code Available (3191)
Date of Event	12/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the screw broke [head detached from shank].It was reported that the unit had been originally implanted a couple weeks prior.It was reported that the patient required revision surgery to remove broken hardware.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection and x-rays.The tulip head was confirmed to be disengaged from the screw shaft.The event resulted in revision surgery.The reported screw has 50 degrees polyaxial freedom.The x-ray image provided indicates that the angulation of the screw to the screw tulip was more than 50 degrees, which may likely have resulted in the disengagement of screw shaft from the tulip head.It is likely that the tulip head disengaged due to excessive angulation of the screw.
Event or Problem Description
It was reported that; the screw broke [head detached from shank].It was reported that the unit had been originally implanted a couple weeks prior.It was reported that the patient required revision surgery to remove broken hardware.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X50MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7215255
• Report Number: 0009617544-2018-00018
• Device Sequence Number: 10804278
• Product Code: KWP
• UDI-Device Identifier: 07613327002249
• UDI-Public: (01)07613327002249
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: 482804750
• Device Catalogue Number: 482804750
• Device Lot Number: 155173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 04/17/2018
• 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